Breast Disease Site

Breast

ID Sort	Study Title	Status Sort
MAC30 (NRG BR009)	A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25 Read More Complexity Level: 2 NCT Registration ID (from clinicaltrials.gov): NCT05879926 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Planned	Planned
I241	A Liquid-biopsy Informed Platform Trial to Evaluate Treatment in CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer The purpose of the pre-study screening is to test for biomarkers. The testing will be done using a sample of your blood. Patients will be sorted into one of the substudies, depending on eligibility and availability. Each substudy will be looking at what effects a new drug has on the patients and their breast cancer, as well as any side effects of the treatment. The purpose of each substudy is to see if the biomarkers that were identified at screening can be used to determine treatment outcomes, like how the cancer cells respond to treatment. Read More Complexity Level: 1 Eligibility: Patients (>=18yrs old, ECOG PS 0-1), life expectancy >=3 mo., must have advanced/metastatic ER+/HER2- breast cancer as per ASCO/CAP criteria that have objective progression on first line CDK4/6i+ET. One subsequent line of endocrine or target therapy is allowed. Pts may have received adjuvant/neoadjuvant systemic therapies; palliative cytotoxic chemotherapy is not permissible. All reversible prior toxicity related to prior therapies must have recovered to grade =<1 and have adequate washout. Measurable disease per RECIST 1.1. Consent to release of tissue block and biopsies. Women/men of childbearing potential must have agreed to use an effective contraceptive method. No history of other malignancies or uncontrolled /serious illnesses which would not permit the patient to be managed per protocol. Hypersensitivity to any of the study drug components. No CNS metastases. No pts who are unable to swallow oral meds/have impairment of GI function. No history of non-compliance. Objectives: Primary: Centrally genotype ctDNA from patients with CDK4/6i+ET resistant ER+/HER2- metastatic breast cancer and evaluate whether biomarker selection improves outcomes as assessed by RECIST 1.1 overall response rate (ORR), or for select studies, clinical benefit rate (CBR). Secondary: Evaluate safety and toxicity of each substudy drug and summarize progression free and overall survival. Exploratory: Create and maintain a tissue/data bank for patients undergoing screening for enrollment to a treatment substudy, evaluate changes in liquid biopsy ctDNA and CTCs as surrogates of treatment outcomes, evaluate potential biomarkers of response, resistance and progression through exploratory corelative studies. NCT Registration ID (from clinicaltrials.gov): NCT05601440 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: January 27, 2023 Chair: (Canada) Dr. David Cescon, University Health Network, (416) 946-2245	Open to Accrual
I241A	Liquid-Biopsy Monitoring for Patients not yet Eligible for Screening and Enrollment The purpose of this study is to monitor and follow your progress through your standard treatment. To do this, tumour tissue and blood samples will be tested for biomarkers, and imaging scans will be looked at to see how they are responding to standard treatment. If progression occurs (cancer gets wose) and the patient needs to start other treatment, the patient may be able to take part in the main treatment portion of the IND.241 trial. Read More Complexity Level: 1 Eligibility: Patients (>=18yrs old), life expectnacy >=3 mo., must have advanced/metastatic ER+/HER2- breast cancer as per ASCO/CAP criteria that are on or about to initiate active treatment with standard first-line therapy with a CDK4/6 inhibitor combined with an aromatase inhibitor.Pts. who have progressed on, or within 12 mo. of completion of adjuvant therapy with an aromatase inhibitor may be treated with fulvestrant instead of an aromatase inhibitor.. Measurable disease per RECIST 1.1. Consent to release of tissue block and biopsies. Not pregnant or breastfeeding. No history of other malignancies or uncontrolled /serious illnesses which would not permit the patient to be managed per protocol. Hypersensitivity to any of the study drug components. No CNS metastases. No pts who are unable to swallow oral meds/have impairment of GI function. No history of non-compliance. Objectives: Primary: To create and maintain a tissue and data bank including tumour and liquid biopsies and clinical data for patients receiving first line endocrine therapy plus CDK4/6i treatment. Exploratory: To evaluate potential biomarkers of response, resistance and progression through exploratorycorrelative studies using ctDNA and CTCs. Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: January 27, 2023 Chair: (Canada) Dr. David Cescon, University Health Network, (416) 946-2245	Open to Accrual
I241B	A Phase II Study of RP-6306 in Patients with CDK4/6-Inhibitor Treated ER+HER2- Metastatic Breast Cancer Receiving Gemcitabine The purpose of this study is to test the good and bad effects of the drug called RP-6306 when you are receiving gemcitabine, a standard chemotherapy drug. The purpose of screening patients for a biomarker is to try and predict which patients are most likely to be helped by RP-6306. To do this a group of patients with or without a biomarker will be enrolled. Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.241. Pts. must have exhausted all standard endocrine therapies including standard fulvestrant. Must not have had prior treatemt with a WEE1 inhibitor, PKMYT1 inhibitor or gemcitabine. Mean resting QTcF =<450 msec/male and =<470 msec/female. Cannot be receiving treatment with medications that prolong the QT interval and/or strong CYP3A inhibitors or inducers within 14 days prior to first dose of study treatment. Objectives: Primary: To centrally genotype ctDNA from patients with CD4/6i-resistant ER+/HER2- metastatic breast cancer (MBC) and evaluate whether biomarker selection improves outcoems as assessed by RECIST 1.1 ORR. Secondary: To evaluate the safety and toxicity profile of RP-6306 with gemcitabine and to summarize progression free and overall survival. Exploratory Objectives: To evlauate changes in liquid bioposy ctDNA and CTCs as surrogates of treatment outcomes and to evaluate potential biomarkers of response, resistance and progression through exploatory correlative studies using ctDNA, CTCs, tissue-based analyses and radiomics. Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Open to Accrual Activation Date: January 27, 2023 Chair: (Canada) Dr. John Hilton, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75086	Open to Accrual
I241C	A Phase II Study of Niraparib, A PARP Inhibitor, in Patients with CDK4/6-Inhibitor Treated ER+/HER2- Metastatic Breast Cancer The purpose of this study is to test the good and bad effects of the drug called niraparib when receiving fulvestrant. The purpose of screening patients for a biomarker is to predict which patients are most likely to be helped by niraparib. To do this, a group of patients with or without a biomarker will be enrolled. Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.241. Patients may have received prior PARPi therapy, but only in the adjuvant setting provided the treatment-free interval is >12 moinths from date of completion of the PARPi. Patients must be eligible for secondline endocrine therapy with fulvestrant as standard of care. Patients must not have had prior history of PRES. Objectives: Primary: To centrally genotype ctDNA from patients with CDK4/6i-resistant ER+/HER2- metastatic breast cancer (MBC) and evaluate whether biomarker selection improves outcomes as assessed by RECIST 1.1 ORR.. To evaluate the safety and toxicity profile of Nirapirab with fulvestrant and to summarize progression free and overall survival. Exploratory: To evaluate changes in liquid biopsy ctDNA and CTCs as surrogates of treatment outcomes and to evaluate potential biomarkers of response, resistance and progression through exploratory correlative studies using ctDNA, CTCs, tissue-based analyses and radiomics. Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Open to Accrual Activation Date: January 27, 2023 Chair: (Canada) Dr. Nathalie Levasseur, BCCA - Vancouver Cancer Centre, (604) 877-6000, (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752	Open to Accrual
MA39 (MA.39)	Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with low risk breast cancer need to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to compare the effects on women with low risk breast cancer of receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back. Read More Complexity Level: 2 Eligibility: 1) Newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases. 2) Must have been treated by BCS or mastectomy with clear margins of excision. 3) Patients with T3N0 disease are eligible. 4) Patients with disease limited to nodal micrometastases are eligible. 5) If treated by an axillary dissection must have 1-3 positive axillary nodes. 6) If treated by a SLNB alone must have only 1-2 positive axillary nodes. 7) Must be ER greater than or equal to 1% and Her2 negative on local testing. 8) Must have an Oncotype DX recurence score of 25 or less. 9) Must consent to provision of tissue and blood for mandatory correlative studies 10) Must have had endocrine therapy initiated or planned for greater than or equal to 5 years 11) ECOG performance status must be 0,1 or 2. 12) Age must be greater than or equal to 35 years. Objectives: Primary: To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC. Secondary: 1) Invasive disease-free survival (DFS); 2) Breast cancer mortality; 3) Overall survival (OS); 4) Locoregional recurrence-free interval (LRRFI); 5) Distant recurrence-free interval (DRFI); 6) Toxicity; 7) Arm volume and mobility 8) Patient reported outcomes (PROs) and Quality of Life (QOL); 9) Cost effectiveness Tertiary: 1) To establish a comprehensive tumour bank; 2) To evaluate the ability of intrinsic subtype to predict study outcomes and the effect of regional RT on these outcomes; 3) To evaluate other radiation signatures to prognosticate and predict effect of regional RT; 4) To describe the prevalence of ctDNA and evaluate its prognostic ability NCT Registration ID (from clinicaltrials.gov): NCT03488693 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: May 30, 2018 Chair: (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495	Open to Accrual
MA40	A Double-Blind Placebo Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor (FINER) A trial comparing ipatasertib and fulvestrant with placebo and fulvestrant in patients with ER positive, HER-2 negative advanced breast cancer. Read More Complexity Level: 2 Eligibility: INCLUSION CRITERIA: Histologically/cytologically confirmed ER+, HER2- breast cancer. Females must be post-menopausal or pre-menopausal with ovarian supression using LHRH agonist. Clinical/radiographic progression during treatment with/within 28 days of discontinuation of 1st line treatment with CDK4/6 inhibitor and AI for advanced disease. Clinicallyradiologically documented disease. 18 years of age or older. ECOG 0 or 1. No concurrent anti-cancer therapy. Must not have received > 1 prior line of treatment with a CDK 4/6 inhibitor + AI in advanced setting. Treatment with CDK 4/6 inhibitor + AI must be most recent treatment. Adequate hematology and organ function.MAIN EXCLUSION CRITERIA: Untreated or symptomatic CNS metastases, radiation for CNS within 28 days. Active inflammatory bowel disease. Prior treatment with fulvestrant, SERDs or PI3K inhibitors. QTc>/=480 msec. Active infections. Type 1/2 diabetes requiring insulin. Hypercholesterolemia. Coagulation disorders. Objectives: PRIMARY: Investigator assessed PFS (per RECIST 1.1) in ipatasertib + fulvestrant vs. placebo + fulvestrant arms SECONDARY: compare treatment arms with respect to investigator assessed PFS in PIK3CA/AKT1/PTEN altered cohort, investigator assessed PFS in non-altered PIK3CA/AKT1/PTEN cohort, PFS as assessed by blinded central radiology review in all patients, response rate (RR) [per RECIST 1.1], duration of response (DoR), clincial benefit rate (CBR), overall survival (OS), time to commencement of subsequent line systemic therapy or death (TSST), safety and tolerability (CTCAE version 5.0). quality of life (QOL) (EORTC QLQ-C30 and PRO-CTCAE), economic evaluation (EQ-5D-5L). TERTIARY: compare PFS in two treatment arms based on PIK3CA/AKT1/PTEN altered status as determined using archival tissue, identification of prognostic biomarkers, creation of a biobank of FFPE, cfDNA, and digital images, characterize pharmacokinetics NCT Registration ID (from clinicaltrials.gov): NCT04650581 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 01, 2020 Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752	Open to Accrual
MAC22 (ECOG-ACRIN EA1151)	Tomosynthesis Mammographic Imaging Screening Trial (TMIST) This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Read More Complexity Level: 3 Eligibility: Patients must be women between the age 45 and 75 at the time of study entry. Women of childbearing potential must not be known to be pregnant or lactating Patients must be scheduled for, or have intent to schedule, a screening mammogram Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol. Written informed consent No symptoms or signs of benign or malignant breast disease No screening mammogram within the last 11 months prior to date of randomization No previous personal history of breast cancer including ductal carcinoma in situ No breast enhancements Objectives: To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen NCT Registration ID (from clinicaltrials.gov): NCT03233191 NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: October 13, 2017 Chair: (Canada) Dr. Martin Yaffe, Odette Cancer Centre, (416) 480-5715	Open to Accrual
MAC26 (SWOG S1706)	A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer. Read More Complexity Level: 2 Eligibility: Patients must be =>18 with a Zubrod Performance Status =< 2. Patients must have adequate: hematologic, renal and hepatic function. Patients must not have: a history of other prior malignancy or uncontrolled infection; a history of resting ECG indicating uncontrolled potential reversible cardia conditions symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia; MDS/AML; major surgery within 2 weeks of starting study treatment; history of uncontrolled ventricular arrhythmia; previous allogenic bone marrow transplant; whole blood transfusions. Patients must be able to swallow and retain oral medication. Objectives: Primary objective is to compare the Invasive Disease-Free Survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. Secondary objective is to compare the effect of concurrent administration of olaparib with radiotherapy versus radiotherapy alone on improvement in locoregional control (measured by Locoregional Recurrence-Free Interval), Distant Relapse-Free Survival, and Overall Survival in inflammatory breast cancer patients. NCT Registration ID (from clinicaltrials.gov): NCT03598257 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: May 28, 2019 Chair: (Canada) Dr. Eileen Rakovitch, Odette Cancer Centre, (416) 480-4974	Open to Accrual
MAC27 (ALLIANCE A011801)	COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib The purpose of this study is to determine how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Read More Complexity Level: 2 Eligibility: Confirmed HER2-positive breast cancer, who received neoadjuvant chemotherapy, have had total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision. Must have axilla evaluated with either sentinel node biopsy or axillary lymph node dissection. Patients must have adequate hepatic, renal, and bone marrow function. Patients must not be pregnant and not nursing, must be 18 years or older (male or female), and ECOG Performance Status of 1 or less. Objectives: The primary objective is to determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high-risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. Secondary objectives: (1) To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: overall survival (OS), breast cancer free survival (BCFS), distant recurrence-free survival (DRFS), disease-free survival (DFS), brain metastases-free survival (BMFS). (2) To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases. NCT Registration ID (from clinicaltrials.gov): NCT04457596 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: March 03, 2022 Chair: (Canada) Dr. Phillip Blanchette, London Regional Cancer Program, (519) 685-8640	Open to Accrual
MAC28 (NRG BR007)	A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage 1, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </=18 Breast Cancer (DEBRA) To evaluate the treatment of low-risk breast cancer with breast conservation surgery (BCS) and hormonal therapy compared to the usual treatment of BCS followed by hormonal therapy and regional radiation therapy. Read More Complexity Level: 2 Eligibility: Patients with resected pT1N0M0, HER2-Negative, ER and/or PgR-Positive Breast Cancer and Oncotype-DX Recurrence Score less than or equal to 18. Objectives: Primary objective: To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. NCT Registration ID (from clinicaltrials.gov): NCT04852887 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: December 23, 2021 Chair: (Canada) Dr. Valerie Theberge, CHUQ-Pavillon Hotel-Dieu de Quebec, (418) 691-5264	Open to Accrual
MAC29 (ALLIANCE A012103)	OptimICE-pCR: De-escalation of Therapy in Early-Stage TNBC Patients who Achieve pCR after Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy Pembrolizumab vs. observation in people with triple-negative breast cancer who had a pathologic complete response after chemotherapy plus pembrolizumab Read More Complexity Level: 2 Eligibility: Patients with a history of stage T1cN1-2 or T2-4N0-2 breast cancer according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both. Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual DCIS is allowed. Isolated tumor cells are considered node-negative. ER and PR ≤10%; HER2-negative. Objectives: To evaluate whether observation results in a non-inferior RFS compared to adjuvant pembrolizumab in early-stage TNBC patients who achieve a pCR after neoadjuvant chemotherapy with pembrolizumab. RFS by stage at presentation and by receipt of prior anthracycline therapy, AE event rate, OS, LRR and QOL by age, race, and ethnicity, AEs related to RTX. NCT Registration ID (from clinicaltrials.gov): NCT05812807 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: March 28, 2024 Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752	Open to Accrual
I236	A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination with Weekly Paclitaxel in Patients with Advanced/Metastatic HER2-Negative Breast Cancer Read More Complexity Level: 1 Eligibility: Histologically and/or cytologically confirmed diagnosis breast cancer that is advanced/metastatic/recurrent or unresectable. Formalin fixed paraffin embedded tissue block available; select number of patients in Phase II must have accessible disease suitable for biopsy. Presence of clinically and/or radiologically documented disease. ECOG 0 or 1. Must have received at least one non-taxane containing chemotherapy regimen for advanced/metastatic disease, unless:relapsed within 6 mos of completion of adjuvant chemo;taxane and/or anthracycline containing adjuvant chemo or;contraindications to chemo other than weekly paclitaxel. Patients may not have had previous TTK/MPS1 inhibitor.Patients with HER2 positive breast cancer not eligible; active or uncontrolled infections, serious illness, significant cardiac or pulmonary disease, history of central nervous system mets or spinal cord compression; concurrent treatment with other investigational drugs; patients treated with full dose warfarin Objectives: Primary: Phase I - To establish the safety and tolerability of CFI-402257 given orally in combination with weekly paclitaxel and to identify the recommended Phase II dose (RP2D) in patients with advanced breast cancer. Phase II: To evaluate the anti-tumour activity of the CFI-402257+Paclitaxel combination when administered at the RP2D by determining Overall Response Rate (ORR). Secondary: To estimate the Clinical Benefit Rate (CBR, defined as CR or PR or stable disease (SD) >16 weeks in duration; to evaluate the safety and tolerability; to explore, if indicated, the PK profile of CFI402257 and paclitaxel. Exploratory: in serial tumour biopsies, explore evidence of pharmacodynamic target effect and estimate CFI402257 levels; evaluate the genomic alterations and other molecular features which may be associated with response and/or clinical benefit NCT Registration ID (from clinicaltrials.gov): NCT03568422 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: October 17, 2018 Closing Date: April 07, 2022 Chair: (Canada) Dr. Philippe Bedard, University Health Network, (416) 946-4501 Ext. 4534	Closed to Accrual
I237	A Phase II Study of CFI-400945 in Patients with Advanced/Metastatic Breast Cancer Read More Complexity Level: 1 Eligibility: Histologically and/or cytologically confirmed diagnosis breast cancer that is advanced/metastatic/recurrent or unresectable and either ER-, PR- and HER2- (COHORT 1) or ER+/PR+, HER2- and PTEN-null (COHORT 2) or ER+/PR+, HER2- and not PTEN-null (COHORT 3). FFPE tissue block available; select number of patients per cohort must have accessible disease suitable for biopsy. Presence of clinically/radiologically documented disease. ECOG 0 or 1. At least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, must have included anthracycline and taxane (unless contraindicated). No limit to number of prior regimens. May have received other therapies (i.e. endocrine therapy, immunotherapy, targeted therapies). HER2+ breast cancer not eligible; active or uncontrolled infections, serious illness, significant cardiac or pulmonary disease, history of CNS mets or spinal cord compression; concurrent treatment with other investigational drugs; treated with full dose warfarin. Objectives: Primary: To evaluate the objective response rate of CFI-400945 in patients with unresectable locally recurrent or metastatic breast cancer. Secondary: To estimate the Disease Control Rate (DCR, defined as CR or PR or stable disease (SD) >16 weeks in duration; to evaluate the safety and tolerability; to evaluate pharmacodynamics and cellular effects on tumour cells through paired tumour biopsies. Tertiary: To evaluate somatic genomic alterations and other molecular features (gene or protein expression levels) associated with response and/prolonged stable disease; to evaluate the association between PTEN status and response; to explore mechanisms of acquired resistance to CFI-400945 and clonal evolution in response to CFI-400945 treatment using cfDNA. NCT Registration ID (from clinicaltrials.gov): NCT03624543 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: December 21, 2018 Closing Date: January 17, 2023 Chair: (Canada) Dr. David Cescon, University Health Network, (416) 946-2245, (Canada) Dr. Rossanna Pezo, Odette Cancer Centre, (416) 480-4757	Closed to Accrual
I239	A Phase II Study of CFI-400945 and Durvalumab in Patients with Advanced/Metastatic Triple Negative Breast Cancer (TNBC) Read More Complexity Level: 1 Eligibility: Histologically and/or cytologically confirmed diagnosis of breast cancer that is advanced/metastatic or unresectable and negative for ER, PR and HER2. FFPE tissue block available; select number of patients must have accessible disease suitable for biopsy. Presence of clinically/radiologically documented disease. ECOG 0 or 1. At least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, must have included anthracycline and taxane. No limit to number of prior regimens. May have received other therapies (i.e. endocrine therapy, targeted therapies). Must not have received prior immunotherapy. Not permitted: Active or uncontrolled infections, active or prior autoimmune or inflammatory disorders, primary immunodeficiency or allogenic organ transplant, serious illness, untreated or uncontrolled cardiovascular conditions, history of CNS mets or spinal cord compression; concurrent treatment with other investigational drugs, treated with full dose warfarin or growth factors. Objectives: Primary Objectives: To evaluate the objective response rate (RECIST 1.1) of CFI-400945 given with durvalumab. Secondary Objectives: To evaluate Disease Control Rate (DCR, defined as CR or PR or stable disease (SD) > 16 weeks in duration) of CFI-400945 given with durvalumab, to evaluate the immune-related response rate (iRECIST) of CFI-400945 given with durvalumab, to establish the safety and tolerability of CFI-400945 given orally in combination with durvalumab in a q4w schedule and to confirm the recommended phase II dose (RP2D) in patients with metastatic triple negative breast cancer (TNBC), and to assess the pharmacodynamic and immune effects of CFI-400945+durvalumab. NCT Registration ID (from clinicaltrials.gov): NCT04176848 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: December 19, 2019 Closing Date: April 26, 2022 Chair: (Canada) Dr. Andrew Robinson, Cancer Centre of Southeastern Ontario at Kingston, (613) 549-6666 Ext. 8104, (Canada) Dr. David Cescon, University Health Network, (416) 946-2245	Closed to Accrual
MA32D (ALLIANCE A211201)	Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32 Read More Complexity Level: 3 Eligibility: Eligible patients must be either concurrently enrolling or previously enrolled to NCIC study MA.32. Eligible patients may be either pre- or post-menopausal. Patients must have hormone receptor-negative breast cancer. Patients must have breast density measurement as defined by either: >/= 25% density, or fibroglandular densities, or BIRAD-2 category or greater. Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to NCIC MA.32 must be available for submission. If the patient has previously enrolled to MA.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission. Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible. Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study). Objectives: To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin or placebo treatment through one year of therapy in patients with hormone receptor negative breast cancer (i.e. not on endocrine therapy). NCT Registration ID (from clinicaltrials.gov): NCT01666171 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: March 18, 2015 Closing Date: October 13, 2017 Chair: (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, (416) 586-8605, (Canada) Dr. Swati Kulkarni, Windsor Regional Cancer Centre, (519) 253-5353	Closed to Accrual
MA33 (TROG 0701)	A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast Read More Complexity Level: 2 Eligibility: Women with DCIS, radial margins >1 mm post-breast conserving therapy. Objectives: Time of local recurrence Overall survival; disease-free survival; cosmetic outcome, acute and late toxicity; correlative studies. NCT Registration ID (from clinicaltrials.gov): NCT00470236 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: April 29, 2009 Closing Date: June 20, 2014 Chair: () Dr. Ivo A. Olivotto, (778) 440-7322	Closed to Accrual
MA34 (BIG 4-11)	A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer Read More Complexity Level: 2 Eligibility: Early breast cancer; HER2 positive centrally confirmed;, PS 0 -1, adequate bone marrow, liver, renal function; LVEF > 50%,blocks available for central collection. T1-4 any with N1 or T1c N0 or T1b NO if another high risk factor such as ER negative, age < 36 or Grade 3. The T1bN0 population will be limited to < 10% of the total population of 3806. Objectives: Primary: Disease Free Survival Secondary: Overall Survival; EFS; QoL; A biologic correlate NCT Registration ID (from clinicaltrials.gov): NCT01358877 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: April 05, 2012 Closing Date: June 28, 2013	Closed to Accrual
MA36 (BIG 6-13)	A Randomised, Double-Blind, Parallel group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy Read More Complexity Level: 2 Eligibility: For inclusion in the study patients should fulfil the following criteria: Provision of informed consent prior to any study specific procedures, female or male patients must be greater than or equal to 18 years of age, histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast that is at surgery: either axillary node-positive (any size) or node negative with primary tumour >2cm for patients who received adjuvant chemotherapy or showing evidence of non pCR for patients who received neoadjuvant chemotherapy. Patients must have a documented mutation in BRCA1 or BRCA2 predicted or suspected deleterious. Submission of (FFPE) tumour sample from the primary tumor is mandatory. Objectives: The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS. Secondary objectives aretTo assess the effect of adjuvant treatment with olaparib on overall survival (OS), to assess the effect of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS), to assess the effect of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer, to assess the effect of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale and to assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis). NCT Registration ID (from clinicaltrials.gov): NCT02032823 Participation: Limited to invited centres; Site Selection Closed NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: July 20, 2015 Closing Date: April 29, 2019 Chair: (Canada) Dr. Andrea Eisen, Odette Cancer Centre, (416) 480-4617	Closed to Accrual
MA37 (BIG 14-03)	PALLAS: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer Read More Complexity Level: 2 Eligibility: Premenopausal and postmenopausal women or men with Stage II (Stage IIA limited to a maximum of 1000 patients) or Stage III early invasive breast cancer. Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2-. Patients must have histologically confirmed hormone receptor positive (ER+ and/or PR+), HER2-, early invasive breast cancer. A formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be transmitted to a central sample repository and confirmation of receipt must be available prior to randomization. Objectives: To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC). To compare the following endpoints: iDFS excluding second primary cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS). To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone. NCT Registration ID (from clinicaltrials.gov): NCT02513394 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: January 25, 2017 Closing Date: November 30, 2018 Chair: (Canada) Dr. Julie Lemieux, CHA-Hopital Du St-Sacrement, (418) 649-5726	Closed to Accrual
MA41 (BIG 19-02)	De-Escalation of adjuvant ChemotheRapy in HER-2 positive, EStrogen reCEptor-negative, Node-negative, early breast cancer patients who achieved pathological complete response after neoadjuvant chemotherapy and Dual HER-2 blOckade (DECRESCENDO) Read More Complexity Level: 2 Eligibility: Male or female, > or = 18 years old, ECOG 0 or 1,tumour measures 15 to 50 mm, histologically confirmed diagnosis of HER2-positive and ER-negative/PR-negative breast cancer, ER-negative/PR-negative, N0, left ventricular ejection fraction > or = 55%, Objectives: To evaluate 3-year RFS in subjects with HER2-enriched, ER-negative/PR-negative, clinically node-negative breast cancers who achieve a pCR after neoadjuvant treatment with weekly paclitaxel (or docetaxel every 3 weeks) and dual HER2 blockade with pertuzumab and trastuzumab FDC SC. To evaluate 3-year RFS in all subjects with HER2-positive, ER-negative/PR-negative, clinically node-negative breast cancers who achieve a pCR after neoadjuvant treatment with weekly paclitaxel (or docetaxel every 3 weeks) and dual HER2 blockade with pertuzumab and trastuzumab FDC SC. To assess pCR rates in the overall population and by primary tumour dimension, 3-year RFS, Recurrence-free interval (RFI), 3-year invasive disease-free survival (iDFS), 3-year distant disease-free survival (dDFS), 3-year overall survival (OS). NCT Registration ID (from clinicaltrials.gov): NCT04675827 Participation: Limited to invited centres; Site Selection Open NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: January 27, 2023 Closing Date: October 02, 2023 Chair: (Canada) Dr. Philippe Bedard, University Health Network, (416) 946-4501 Ext. 4534	Closed to Accrual
MAC11 (SWOG S0221)	A Phase III Trial of Continuous Schedule AC + G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer. Read More Complexity Level: 2 Eligibility: Patients must be women or men with histological confirmed diagnosis of operable Stage I, II, or III invasive breast cancer with known Estrogen and Progesterone status. Patients with T4 tumours are not eligible. Objectives: To compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 4 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel. To comapre the overall survival, toxic effects and to correlate outcome with putative prognostic markers in patients treated with these regimens. NCT Registration ID (from clinicaltrials.gov): NCT00070564 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: November 22, 2006 Closing Date: January 15, 2012 Chair: (Canada) Dr. Jean Latreille, Hopital Charles LeMoyne, (450) 466-5009	Closed to Accrual
MAC12 (ECOG PACCT-1)	Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial Read More Complexity Level: 2 Eligibility: Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment. ER and/or PR-positive Negative axillary nodes Tumor size 1.1-5.0cm (or 5mm-1.0cm) plus unfavorable histological features. Objectives: Primary: To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal. To create a tissue and specimen bank for patients enrolled in this trial. Secondary: To determine whether adjuvant hormonal therapy is sufficient treatment for women whose tumors meet established clinical guidelines. The primary study endpoint is disease-free survival; other co-primary endpoints include distant recurrence free interval, recurrence free interval, and overall survival. NCT Registration ID (from clinicaltrials.gov): NCT00310180 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: September 21, 2006 Closing Date: October 06, 2010 Chair: (Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, (416) 480-4616	Closed to Accrual
MAC15 (SWOG S1007)	A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx For Positive Node, Endocrine Responsive Breast Cancer. Read More Complexity Level: 3 Eligibility: Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status. Objectives: Primary: Disease Free Survival Secondary: Overall survival; EFS; Economic; QoL; A biologic correlate NCT Registration ID (from clinicaltrials.gov): NCT01272037 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: October 05, 2011 Closing Date: October 15, 2015 Chair: (Canada) Dr. Sukhbinder Dhesy-Thind, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64431, (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752	Closed to Accrual
MAC18 (ALLIANCE A221405)	POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy Read More Complexity Level: 3 Eligibility: Premenopausal women with endocrine responsive early breast cancer who received adjuvant endocrine therapy for 18 to 30 months, are between 18 and 42 years of age at enrollment, and wish to interrupt endocrine therapy to attempt pregnancy. Objectives: Primary objective: To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy (ET) to permit pregnancy. Secondary objective: To evaluate factors associated with pregnancy success after interruption of endocrine therapy. NCT Registration ID (from clinicaltrials.gov): NCT02308085 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: March 16, 2016 Closing Date: January 02, 2020 Chair: (Canada) Dr. Ellen Warner, Odette Cancer Centre, (416) 480-4617	Closed to Accrual
MAC19 (ALLIANCE A011202)	A Randomized Phase III Trial Evalulating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy Read More Complexity Level: 2 Eligibility: Please refer to the protocol for a complete list of eligibility criteria. Patients > 18 years of age. Clinical stage T1-3 N1 M0 breast cancer at Dx prior to start of neoadjuvant chemotherapy. No inflammatory breast cancer. No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix. Axillary ultrasound with FNA or core needle biopsy of axillary lymph nodes at time of diagnosis documenting axillary metastasis prior to or within 14 days of starting neoadjuvant chemotherapy. ER, PgR and HER-2 status (by IHC and/or ISH) evaluated from diagnostic core bx prior to start of neoadjuvant chemotherapy Pt must have completed at least 4 cycles of neoadjuvant chemotherapy prior to surgery Objectives: Primary: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy. NCT Registration ID (from clinicaltrials.gov): NCT01901094 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: December 17, 2015 Closing Date: July 01, 2022 Chair: (Canada) Dr. Steven Latosinsky, London Regional Cancer Program, (519) 685-8500 Ext. 58740	Closed to Accrual
MAC20 (ALLIANCE A011401)	Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer Read More Complexity Level: 3 Eligibility: Adult women with histologic diagnosis of invasive HER2 negative breast cancer within the past 12 months, who have a BMI >=27 kg/m^2 at the time of enrollment, who have completed all adjuvant or neoadjuvant chemotherapy and surgery, who do not have diabetes or comorbid conditions that would cause life expectancy of <4 years, and who have a self-reported ability to walk at least 2 blocks (at any pace). Objectives: Primary Objective: Effect of supervised weight loss intervention plus health education materials vs. health education materials alone on invasive disease free survival in overweight and obese women. Secondary Objectives: Relationship between weight change and iDFS/clinical benefit; OS, distant DFS, weight/body composition, insulin resistance; Impact of supervised weight loss intervention on iDFS within subgroups of women (hormone receptor positive vs. negative breast cancer; premenopausal vs. menopausal); Quality of Life (QoL); physical activity and dietary intake; Patient reported outcomes (PRO). NCT Registration ID (from clinicaltrials.gov): NCT02750826 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: November 11, 2016 Closing Date: February 15, 2021 Chair: (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, (416) 586-8605, (Canada) Dr. Vanessa Bernstein, BCCA - Vancouver Island Centre, (250) 519-5571	Closed to Accrual
MAC23 (ALLIANCE A221505)	RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction Read More Complexity Level: 2 Eligibility: This study will recruit women and men >=18 post mastectomy due to invasive breast cancer with planned chest wall reconstruction and radiation. Patients will be approached based on the following main criteria: no prior radiation therapy to the chest, neck or axilla, no prior history of ipsilateral breast cancer, no history of prior or concurrent contralateral invasive breast cancer, negative inked histologic margins from mastectomy pathology and Zubrod performance status of 0-1 Objectives: To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. Secondary objectives include: acute and late radiation complications, based on CTCAE 4.0 toxicity, local and local regional recurrence rate, photographic cosmesis 24 months after radiation, lymphedema at 24 months after radiation, patient satisfaction and well-being at 24 months after radiation (BreastQ,)compare reconstruction complication rates based on reconstruction method and timing of reconstruction, cost and healthcare utilization based on hypofractionation and reconstruction technique NCT Registration ID (from clinicaltrials.gov): NCT03414970 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: March 27, 2018 Closing Date: August 11, 2021 Chair: (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495	Closed to Accrual
MAC24 (SWOG S1418)	A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy Read More Complexity Level: 2 Eligibility: Histologicaly confirmed triple negative breast cancer, must not have metastatic or locally recurrent disease, must have available minimum of five unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node. Patients must have had neoadjuvant chemotherapy followed by surgery, completed their final breast surgery, must be 18 years or older, and Zubrod Performance Status of 2 or less Objectives: Primary objective is to compare invasive disease-free survival of patients with triple-negative breast cancer who have either >/=1 cm residual invasive breast cancer and/or positive lymph nodes (>ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 adjuvant therapy compared to no MK-3475, in both the entire study population and also in the PD-L1 positive subset. Secondary objectives: 1. To compare the effects of MK-3475 on overall survival and distant recurrence-free survival between the two randomized arms for the PD-L1 positive patients and then all patients.2. To assess the toxicity and tolerability of MK-3475 in this patient population with or without radiation therapy. BAHO Study objectives: 1.examine the association between biomarkers of inflammation and quality of life and patient-reported outcomes between the two groups during and at the end of therapy and to examine the long-term and late effects of treatment on patient-reported outcomes. NCT Registration ID (from clinicaltrials.gov): NCT02954874 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: December 11, 2018 Closing Date: June 30, 2021 Chair: (Canada) Dr. Christine Desbiens, CHA-Hopital Du St-Sacrement, (418) 682-7511	Closed to Accrual
MAC25 (NRG-BR004)	A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer Read More Complexity Level: 2 Eligibility: This study will recruit women and men =>18 with ECOG performance status 0-1 with histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease (HER 2-positive). Patients must have measurable disease based on RECIST 1.1. Adequate hematologic, hepatic and renal function within 14 days prior to randomization is required. Patients must not have cardiac disease history and history or risk of autoimmune disease. Objectives: The primary objective is to determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane will improve the PFS, assessed by investigator using RECIST 1.1 criteria, relative to a regimen of a taxane, pertuzumab, trastuzumab, and placebo in patients with newly documented HER2-positive measurable metastatic breast cancer. Secondary objectives include determining whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will: improve the overall survival relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo; improve the overall objective response, assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo; improve PFS, OR, and/or duration of objective response assessed by retrospective blinded central review using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzuma and placebo. NCT Registration ID (from clinicaltrials.gov): NCT03199885 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: January 08, 2020 Closing Date: May 20, 2022 Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752	Closed to Accrual
MAC4 (IBCSG 24-02)	A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer Read More Complexity Level: 2 Eligibility: Premenopausal women (estradiol (E2) levels in the premenopausal range) with histologically proven, resected breast cancer with ER and/or PR positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy. Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by either long-term use of GnRH analogue or surgical oophorectomy or ovarian irradiation) plus tamoxifen compared with tamoxifen alone for premenopausal women with steroid hormone receptor positive early invasive breast cancer who either receive no adjuvant chemotherapy or remain premenopausal following adjuvant and/or neoadjuvant chemotherapy. In addition, the worth of exemestane will be evaluated for this premenopausal patient population by comparing ovarian function suppression plus exemestane with tamoxifen alone and by comparing ovarian function suppression plus exemestane with ovarian function suppression plus tamoxifen. NCT Registration ID (from clinicaltrials.gov): NCT00066690 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: October 07, 2003 Closing Date: April 30, 2010	Closed to Accrual
MAC5 (IBCSG 25-02)	A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer Read More Complexity Level: 2 Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy. Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue) plus exemestane compared with GnRH analogue plus tamoxifen for premenopausal women with steroid hormone receptor positive early invasive breast cancer. Patients may either receive no chemotherapy or commence chemotherapy at the same time that GnRH analogue is initiated NCT Registration ID (from clinicaltrials.gov): NCT00066703 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: October 07, 2003 Closing Date: March 11, 2011	Closed to Accrual
I129	A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 14, 2000 Closing Date: March 02, 2001	Permanently Closed
I132	A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer Read More Eligibility: Women with histologically documented advanced or metastatic breast cancer. Clinically and/or radiologically assessable disease. Unidimensional measurable disease. Prior adjuvant chemotherapy and/or up to two prior chemotherapy regimens for metastatic disease permitted. Objectives: To assess the efficacy (measured by objective tumour response) of temozolomide when given in this schedule in this patient population. To determine the duration of response, time to progression and the toxic effects of temozolomide when administered in this fashion. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 01, 2000 Closing Date: September 26, 2001	Permanently Closed
I163	A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer Read More Eligibility: Patients with recurrent or metastatic breast cancer incurable by other means. Prior adjuvant as well as up to one prior regimen for recurrent/metastatic disease is permitted. Measurable disease. Paraffin embedded tumour sample available for study. Objectives: To evaluate, in parallel, the anti-tumour efficacy of two oral treatment schedules of RAD001C. To assess the adverse events, time to progression and response duration of RAD001C in patients with recurrent/metastatic breast cancer. NCT Registration ID (from clinicaltrials.gov): NCT00255788 Participation: Participation in this study is restricted to invited centres. NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 19, 2005 Closing Date: January 11, 2007	Permanently Closed
I164	A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer Read More Eligibility: Women with histologically documented breast cancer with metastatic or locally disease refractory to standard curative therapy. Prior adjuvant chemotherapy permissible; up to one prior chemotherapy regimen for metastatic disease and no prior taxane for metastatic disease. Prior hormonal therapy permitted, prior radiation therapy permitted if radiation involved <30% functioning bone marrow and >4 weeks. HER-2 positive patients may have had prior Herceptin treatment. ECOG 0,1,2. No brain metastases, no pre-existing neuropathy >= grade 2, no therapeutic anti-coagulation. Objectives: To determine the efficacy, as measured by objective tumour response rate, of weekly OGX-011 and q 3 weekly docetaxel when given in combination to patients with advanced breast cancer. To assess the adverse events, tolerability, time to progression and overall survival in this population. To measure evidence of OGX-011 effect on serum clusterin levels. NCT Registration ID (from clinicaltrials.gov): NCT00258375 Participation: CAKO, CALM, CAMN, CAMP, CANL, CAVA, CAVF, CAVK NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 27, 2005 Closing Date: September 29, 2006	Permanently Closed
I18	NCIC CTG Phase II Study of Flutamide in Breast Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 27, 1985 Closing Date: March 01, 1986	Permanently Closed
I19	NCIC CTG Phase II Study of Menogaril in Breast Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 30, 1985 Closing Date: March 15, 1986	Permanently Closed
I197	A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer. Read More Complexity Level: 2 Eligibility: Advanced or recurrent/metastatic invasive breast cancer, that is ER, PR and HER2 negative. Objectives: To determine the anti-tumour activity and toxicity of foretinib in this patient population. NCT Registration ID (from clinicaltrials.gov): NCT01147484 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 25, 2010 Closing Date: August 02, 2013	Permanently Closed
I198	A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer Read More Complexity Level: 1 Eligibility: Histologically confirmed diagnosis of invasive breast cancer, that is HER2 positive as assessed by FISH or ICH 3+ staining (in accordance with ASCO guidelines) on the basis of local evaluation of HER2 status. Objectives: To determine the recommended phase II dose (RP2D) of foretinib in combination with lapatinib, administered as a continuous daily oral dose, in patients with recurrent or metastatic HER2+ breast cancer. To evaluate the PK of lapatinib when given in combination with foretiib, preliminary evidence of anti-tumour activity, and to investigate the relationship between biomarkers and response. NCT Registration ID (from clinicaltrials.gov): NCT01138384 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 03, 2010 Closing Date: March 05, 2013	Permanently Closed
I35	NCIC CTG Phase II Study of CMF/Lonidamine in Breast Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 08, 1986 Closing Date: January 08, 1988	Permanently Closed
I45	NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 27, 1989 Closing Date: April 15, 1990	Permanently Closed
I4B	NCIC CTG Phase II Study of Lonidamine in Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 01, 1983 Closing Date: May 13, 1985	Permanently Closed
I60	NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 29, 1990 Closing Date: September 17, 1991	Permanently Closed
I68	NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 01, 1992 Closing Date: June 30, 1993	Permanently Closed
I73	NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 27, 1992 Closing Date: February 28, 1995	Permanently Closed
I93	NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 24, 1996 Closing Date: September 24, 1998	Permanently Closed
I97	NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 10, 1996 Closing Date: January 06, 1998	Permanently Closed
MA1	NCIC Cooperative Clinical Trial of Tamoxifen versus Ovarian Ablation in the Treatment of Metastatic Breast Carcinoma in Premenopausal Women Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 06, 1981 Closing Date: May 30, 1983	Permanently Closed
MA10 (10921)	A Multicentre Randomized Study of Dose-Intensive Chemotherapy as Primary Treatment in a Multimodality Approach for Locally Advanced/Inflammatory Breast Cancer (EORTC - NCIC CTG - SAKK Study) Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: August 13, 1993 Closing Date: April 02, 1996	Permanently Closed
MA11	A Phase I Study of Escalating Epirubicin and Cyclophosphamide in Combination with 5-Fu Using Granulocyte Colony Stimulating Factor Support in Premenopausal Women With Axillary Node Positive Operable Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 30, 1993 Closing Date: August 24, 1995	Permanently Closed
MA12	Double-Blind Randomized Trial of Tamoxifen versus Placebo in Patients with Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy Read More NCT Registration ID (from clinicaltrials.gov): NCT00002542 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 20, 1993 Closing Date: April 28, 2000	Permanently Closed
MA13 (9082)	A Randomized, Comparative Study of High Dose CPA/cDDP/BCNU and ABMS versus Standard Dose CPA/cDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Operable Stage II or Stage II Breast Cancer Involving > 10 Axillary Lymph Nodes Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 10, 1993 Closing Date: May 29, 1998	Permanently Closed
MA14	A Randomized Trial of Antiestrogen Therapy versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women Read More NCT Registration ID (from clinicaltrials.gov): NCT00002864 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 24, 1996 Closing Date: July 21, 2000	Permanently Closed
MA15	A Phase I/II Study of Docetaxel and Epirubicin as First Line Therapy for Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): NCT00002866 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 12, 1996 Closing Date: March 20, 2001	Permanently Closed
MA16	A Randomized Comparative Trial of High-Dose Chemotherapy and Autologous Stem Cell Support versus Standard Therapy Following Response to Anthracycline- or Taxane-Based Chemotherapy in Women With Metastatic Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): NCT00003032 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 25, 1997 Closing Date: June 18, 2001	Permanently Closed
MA17 (MA17)	A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen Read More Complexity Level: 2 Eligibility: Post-menopausal women who had receptor-positive breast cancer, or unknown receptor status breast cancer, and have completed at least five years of adjuvant tamoxifen therapy. Objectives: To compare disease-free survival and overall survival. To compare incidence of contralateral breast cancer, and long-term clinical and laboratory safety. To evaluate overall quality of life. NCT Registration ID (from clinicaltrials.gov): NCT00003140 Participation: Open to centres in participating cooperative groups. NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 24, 1998 Closing Date: September 04, 2002	Permanently Closed
MA17B	The Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen -- a Companion Study to MA.17 Read More Eligibility: Eligible women will have a BMD T score greater than or equal to 2.0 SD below the mean value of peak bone mass in young normal women. They must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget¿s disease, uncontrolled thyroid disease, Cushing¿s disease, other pituitary diseases, or other bone diseases. Women must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time, any drug including bisphosphonates for the prevention of osteoporosis within the past six months, or long term use of coumarins. Objectives: To evaluate the effects of letrozole on bone mineral density in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer. NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to MA.17 participants NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 26, 2000 Closing Date: August 30, 2002	Permanently Closed
MA17L	The Influence of Letrozole on Serum Lipid Concentrations in Women with Primary Breast Cancer Who Have Completed Five Years of Adjuvant Tamoxifen -- A Companion Study to MA.17 Read More Eligibility: MA.17 patients, who are non-hyperlipidemic and not taking lipid lowering agents. Objectives: To evaluate the effects of letrozole on serum lipid parameters in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer. NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to MA.17 participants NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 09, 1999 Closing Date: May 02, 2002	Permanently Closed
MA17R (MA17R)	A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study) Read More Complexity Level: 2 Eligibility: Women completing around five years of aromatase inhibitor therapy, either as initial therapy or after tamoxifen, including those who received letrozole within the MA.17 study, are eligible for randomization to a further five years of letrozole or placebo. Eligible subjects must be free of recurrent breast cancer and have completed the five years of aromatase inhibitor therapy no more than 2 years prior to randomization. BMD measured by DEXA should be done within 4 weeks prior to randomization if not done within the previous 12 months, but the results do not affect eligibility. Objectives: To compare the disease-free survival of subjects who receive 5 years of letrozole or placebo after having received around 5 years (4.5 - 6) of aromatase inhibitor therapy (letrozole, anastrozole, or exemestane) including those who received 5 years of adjuvant letrozole as part of the MA.17 trial. To evaluate the effect on overall (all cause specific) mortality. To evaluate the incidence of contralateral breast cancer. To evaluate the long term clinicial and laboratory safety of aromatase inhibitor therapy which includes 5 years of letrozole therapy. To evaluate overall quality of life (SF-36) and menopausal specific QOL (Menqol). To test the hypothesis that common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for the aromatase inhibitor letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy. NCT Registration ID (from clinicaltrials.gov): NCT00754845 Participation: Open to centres in participating cooperative groups. NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 14, 2004 Closing Date: May 08, 2009	Permanently Closed
MA19	A Phase III Study of DPPE (BMS-217380-01) Combined With Doxorubicin versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 09, 1998 Closing Date: July 08, 1999	Permanently Closed
MA2	Pilot Study of Sequential Hormono-Chemotherapy in Metastatic Breast Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 04, 1981 Closing Date: August 20, 1982	Permanently Closed
MA20	A Phase III Study of Regional Radiation Therapy in Early Breast Cancer Read More Complexity Level: 2 Eligibility: Pre or post menopausal women with node positive and high risk node-negative breast cancer treated by breast conserving therapy and currently accepted adjuvant chemotherapy and/or hormonal therapy. Objectives: To determine if regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) in addition to breast radiation prolongs survival in women with early breast cancer compared with breast radiation alone. To compare disease free survival, isolated local regional disease-free survival, and distant disease free survival. To evaluate toxicity. To evaluate quality of life. To determine the cosmetic outcome of these two treatment approaches. NCT Registration ID (from clinicaltrials.gov): NCT00005957 Participation: Not limited. NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 14, 1999 Closing Date: February 02, 2007	Permanently Closed
MA21 (MA21)	A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer Read More Complexity Level: 2 Eligibility: Women with histologically confirmed adenocarcinoma of the breast treated with either total or partial mastectomy; node positive or high risk node negative; T0-T4, N0, N1, or N2, M0; ER status must be known; < 60 years of age; no prior chemotherapy, hormonal therapy, immunotherapy or radiotherapy for breast cancer; adequate blood counts; ECOG < 2; LVEF > institutional lower normal limit; no history of cardiac disease. Objectives: To compare disease-free survival and overall survival among the three treatment arms. To compare rate of toxicities and quality of life among the three treatment arms. NCT Registration ID (from clinicaltrials.gov): NCT00014222 Participation: Not Limited NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 04, 2000 Closing Date: April 29, 2005	Permanently Closed
MA22	A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer Read More Complexity Level: 2 Eligibility: To determine MTD and recommended phase II dose of docetaxel and epirubicin with pegfilgrastim in a phase I dose escalation study as 1st line therapy. To evaluate toxicity of the combination at the recommended phase II dose. To evaluate response rate and duration of the combination as first-line therapy at the recommended phase II dose. Objectives: Women with locally advanced or inflammatory breast cancer; no previous surgical systemic or radiation treatment for breast cancer other than biopsy for diagnosis; ECOG 0, 1, 2; adequate blood counts; LVEF > institutional lower normal limit; no history of cardiac disease. NCT Registration ID (from clinicaltrials.gov): NCT00066443 Participation: Limited NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 25, 2003 Closing Date: June 08, 2009	Permanently Closed
MA23 (10951)	Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients Read More Eligibility: Postmenopausal patients with locally recurrent inoperable or metastatic carcinoma of the breast. Patients must have had histologically or cytologically confirmed adenocarcinoma of the breast at original diagnosis. At study entry the patient must have had metastatic progressive or locally recurrent inoperative breast cancer. Patients must have positive estrogen or progesterone receptor status at the time of original diagnosis or subsequently at a metastatic site. Objectives: To determine if a hormonal therapy with exemestane is superior in terms of progression-free survival to tamoxifen in first line advanced breast cancer. To further document the safety profile of exemestane and to compare overall survival between the treatment arms. NCT Registration ID (from clinicaltrials.gov): NCT00002777 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: August 08, 2001 Closing Date: September 20, 2002	Permanently Closed
MA25 (S9927)	Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes Read More Eligibility: Women with histologically confirmed adenocarcinoma of the breast, with the primary tumour < 5 cm and 1-3 positive axillary nodes (pathologic T1-2, pathologic N1). Patients with apocrine, adenocystic, or squamous carcinomas or sarcomas of the breast or bilateral breast cancer are not eligible. Objectives: To compare overall and disease-free survival in pre- and post-menopausal women with Stage II breast cancer and 1 ¿ 3 positive nodes treated with or without radiation therapy following mastectomy and adjuvant chemotherapy. To assess local-regional control for this cohort of patients. To assess the potential toxicities of radiotherapy delivered using CT-directed treatment in this cohort of patients. NCT Registration ID (from clinicaltrials.gov): NCT00005983 Participation: Limited to centres with current CPA/FWA # NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: November 22, 2001 Closing Date: June 15, 2003	Permanently Closed
MA27 (MA27)	A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer Read More Eligibility: Post-menopausal women who have histologically or cytologically confirmed, receptor-positive, adequately excised, primary breast cancer are eligible for this trial. Adjuvant chemotherapy and radiation are allowable. Chemotherapy must be completed before randomization. Radiotherapy may be given prior to or concurrently with protocol therapy. Objectives: To compare event free survival (EFS) between women treated with Exemestane or Anastrozole as adjuvant therapy. To compare the incidence of contralateral breast cancer, the time to distant recurrence, survival & safety among treatment groups. NCT Registration ID (from clinicaltrials.gov): NCT00066573 Participation: NCIC CTG, CTSU sites, IBCSG NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 02, 2003 Closing Date: July 31, 2008	Permanently Closed
MA27B (MA.27B)	The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27 Read More Eligibility: MA.27 patients who have a bone mineral density measurement (using DEXA: dual energy x-ray absorptiometry) done within 12 weeks prior to randomization to the MA.27 core protocol may participate in the companion protocol. In order to be eligible patients must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget's disease, uncontrolled thyroid disease, Cushing's disease, other pituitary diseases, or other bone diseases. Patients must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time or be on long term treatment with coumarins Objectives: The primary objective is to examine whether there is a clinically relevant difference in impact on BMD between the steroidal (exemestane) and the non-steroidal (anastrozole) agents at 2 years NCT Registration ID (from clinicaltrials.gov): NCT00354302 Participation: Limited to MA.27 participants NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 24, 2006 Closing Date: May 30, 2008	Permanently Closed
MA27D (N0434)	The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27 Read More Eligibility: MA.27 patients with one intact non-cancerous breast with no hormone, SERM or GnRHA therapy within the past 12 months and no hormone, SERM or GnRHA therapy within 6 months prior to the pre-registration mammogram are eligible for this companion study to MA.27 Objectives: To assess the change in percent breast density and change in dense area in response to aromatase inhibitor therapy, whether these changes correlate with changes in plasma hormones and whether these changes, over time, are associated with recurrence of breast cancer NCT Registration ID (from clinicaltrials.gov): NCT00316836 Participation: Limited to MA.27 participants NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: April 24, 2006 Closing Date: July 31, 2008	Permanently Closed
MA29 (MA29)	A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast. Read More Eligibility: Women with newly diagnosed, histopathologically confirmed, T1c, T2 or T3 unifocal, operable, carcinoma of the breast (prior to surgery). Objectives: PRIMARY: To assess the feasibility of administering oral sunitinib pre-operatively, to patients with newly diagnosed, histopathologically confirmed T1c, T2 or T3 unifocal, operable carcinoma of the breast. SECONDARY: - toxicity - tumour response (RECIST) - pharmacodynamic endpoints [treatment-induced changes (1) in the levels of tumour and plasma-soluble markers of angiogenesis, (2) in the protein/RNA levels of host and tumour-specific genes involved in response and toxicity to sunitinib, (3) on vascular parameters (DCE-MRI), (4) on cell death and tumour microcirculation (spectroscopic and microbubble contrast-enhanced ultrasound) and (5) on tumour metabolic activity (18-FDG-PET)] - tumour banking (optional) NCT Registration ID (from clinicaltrials.gov): NCT00482755 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 12, 2007 Closing Date: March 15, 2010	Permanently Closed
MA38 (MA38)	Randomized Phase II Study Comparing Two Different Schedules of Palbociclib plus Second Line Endocrine Therapy in Women with Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer Read More Complexity Level: 2 Eligibility: Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. Confirmed diagnosis of ER positive breast cancer Postmenopausal status or pre/perimenopausal women suitable for ovarian suppressive therapy Progressed on prior endocrine therapy for advanced disease or within 12 months of adjuvant endocrine therapy Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease Eastern Cooperative Oncology Group [ECOG] 0-2 Adequate organ and marrow function Objectives: Primary: Progression Free Survival Secondary: Adverse Events, Safety and Tolerability, Response Rate (in patients with measurable disease), Duration of Response, Clinical Benefit Rate, Overall Survival, Patient Reported Quality of Life using EORTC QLQC 30 and trial specific checklist, population PK/PD markers of drug effect in a subgroup of patients on both arms NCT Registration ID (from clinicaltrials.gov): NCT02630693 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 16, 2015 Closing Date: February 10, 2017	Permanently Closed
MA4	National Cancer Institute Of Canada Cooperative Clinical Trial Of Adjuvant Post-Surgical Treatment Of Breast Carcinoma In Post-Menopausal Patients With Histologically Involved Axillary Nodes Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 13, 1984 Closing Date: December 31, 1990	Permanently Closed
MA5	Cooperative Clinical Trial of Intensive CEF versus Standard CMF as Adjuvant Therapy for Breast Carcinoma in Premenopausal Patients With Histologically Involved Axillary Nodes Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 01, 1989 Closing Date: July 30, 1993	Permanently Closed
MA6A	Phase I Study of Fluorouracil, Doxorubicin and Vinorelbine (FAN) in Patients With Advanced Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 06, 1992 Closing Date: July 07, 1994	Permanently Closed
MA7A	Phase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 10, 1992 Closing Date: May 24, 1994	Permanently Closed
MA8	A Phase III Comparative Study of Vinorelbine Combined With Doxorubicin versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 15, 1992 Closing Date: July 17, 1995	Permanently Closed
MA9 (8814)	Phase III Comparison of Adjuvant Chemoendocrine Therapy with CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients with Involved Axillary Lymph Nodes and Positive Receptors Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: November 21, 1991 Closing Date: July 31, 1995	Permanently Closed
MA9C (8854)	Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: May 01, 1996 Closing Date: October 01, 1998	Permanently Closed
MAC14 (ECOG-ACRIN 2108)	A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer Read More Complexity Level: 2 Eligibility: 3.1 Registration (STEP 1) 3.1.1 Patients (male or female) must have an intact primary (not recurrent) invasive carcinoma of the breast. Biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast. 3.1.2 Patients with synchronous contralateral breast cancer are excluded. 3.1.3 Patients should have at least one site of distant metastatic disease. If only a single metastatic lesion is present, biopsy is mandatory. See Section 3.1.6. 3.1.4 Radiology reports documenting status of disease prior to initiation of systemic therapy must be available. Scans must have been completed within 4 weeks prior to start of systemic therapy. 3.1.5 If patient has only one site of metastatic disease, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available. Single metastatic lesion? Objectives: Primary Objectives To evaluate whether early local therapy of intact primary disease in women with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to women who receive local therapy for palliation only NCT Registration ID (from clinicaltrials.gov): NCT01242800 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 22, 2011 Closing Date: July 23, 2015	Permanently Closed
MAC2 (B-33)	A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy (NSABP: B-33). Read More NCT Registration ID (from clinicaltrials.gov): NCT00016432 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 03, 2002 Closing Date: October 09, 2003	Permanently Closed
MAC21 (ALLIANCE A011502)	A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial Read More Complexity Level: 3 Eligibility: Histologic documentation of women or men with node-positive, HER2 negative, anatomic Stage II or III breast carcinoma or high risk node negative (defined as ER negative and tumor size >2 cm)within one year of diagnosis and free of recurrence. Patients with pN1mic are eligible. Patients must be enrolled within 1 year after diagnosis. Patients must be >= 18 and < 70 years of age. ECOG performance status 0-2. Any ER/PgR status allowed. Objectives: Primary Objective: To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients. Secondary Objectives: To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon: a) Distant disease-free survival, b) Overall survival, c) Cardiovascular disease, To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers. To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation NCT Registration ID (from clinicaltrials.gov): NCT02927249 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: September 29, 2017 Closing Date: December 04, 2020	Permanently Closed
MAC3 (E2100)	A Randomized Phase III Trial of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer. Read More Eligibility: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast with measurable or nonmeasurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent. All scans or x-rays used to document measurable or nonmeasurable disease must be done within 4 weeks prior to randomization. Patients with breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin. HER-2 testing is strongly encouraged. Therefore patients with unknown HER-2 status are not eligible unless the treating physician has determined that Herceptin-based therapy would be inappropriate or not indicated. Patients must not have had prior chemotherapy for locally recurrent or metastatic breast cancer. Prior hormonal therapy for locally recurrent or metastatic disease is allowed, but this must have been discontinued Objectives: To determine the time to treatment failure of patients with chemotherapy naive metastatic breast cancer randomized to treatment with either paclitaxel alone or paclitaxel plus bevacizumab. To compare the objective response rate, duration of response, overall survival and time to progression of paclitaxel to that of the combination of paclitaxel plus bevacizumab. To compare the toxicity of paclitaxel to that of paclitaxel in combination with bevacizumab. To compare the quality of life (FACT-B) of patients treated with paclitaxel to that of the combination of paclitaxel plus bevacizumab as first-line therapy for metastatic breast cancer. To compare changes in surrogate markers of angiogenesis and response including VEGF and VCAM-1 expression during treatment with paclitaxel to that of paclitaxel plus bevacizumab. NCT Registration ID (from clinicaltrials.gov): NCT00028990 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 26, 2002 Closing Date: May 26, 2004	Permanently Closed
MAC6 (26-02)	A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer who Receive Endocrine Therapy Read More Complexity Level: 2 Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors for whom there is an uncertain role for adding chemotherapy to the adjuvant treatment program. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy. Objectives: This trial will evaluate the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy will be determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane will be determined by the investigator. Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: August 04, 2003 Closing Date: November 22, 2005	Permanently Closed
MAC8 (NSABP B-37)	A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer. Read More Complexity Level: 2 Eligibility: Histologically proven local &/or regional recurrence of invasive breast cancer following primary treatment with mastectomy or breast conserving treatment. Surgical resection with radiotherapy (ro) or (ri). No evidence of distant mets. Measurement of hormone receptors in the recurrent tumour. Medically suitable for chemo of 3-6 months. Completed baseline QOL. Informed consent and agree to data and material transfer. Geographically accessible for f/u. Objectives: Primary: To determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer. Secondary: To determine systemic disease-free and overall survival; sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer; and to determine the quality of life of patients treated with this regimen. NCT Registration ID (from clinicaltrials.gov): NCT00074152 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: February 11, 2005 Closing Date: November 30, 2007	Permanently Closed
MAP1	A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density Read More Eligibility: Healthy, postmenopausal women or those postmenopausal women who have had prior breast cancer with a receptor positive tumour, either ER or PR or equivocal or unknown breast cancer or who have had prior DCIS (receptor status not required), who have either not had adjuvant endocrine therapy or are more than six months from the completion of adjuvant endocrine therapy and who are eligible by virtue of the appearance of increased radiological density, grade 4, 5 or 6, on routine mammographic screening Objectives: To determine the proportion of women who have a decrease in breast density of at least one grade after treatment for one year; to determine if the decrease in density grade is sustained one year after cessation of therapy; to evaluate specific changes related to other end-organ effects i.e. bone density, lipid metabolism, etc. NCT Registration ID (from clinicaltrials.gov): NCT00238316 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 05, 2000 Closing Date: June 09, 2006	Permanently Closed
MAP2	A Randomized Study of the Effect of Exemestane (Aromasin) versus Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer Read More Eligibility: Healthy, postmenopausal women who have increased radiological density occupying >25% of the breast tissue on routine screening mammogram. Objectives: To determine whether treatment with exemestane for one year in women with spontaneously increased breast density leads to a decrease in breast density of at least >1 grade 12 months after randomization; to determine if the decrease in breast density grade is sustained one year after stopping treatment; to determine the correlation between the grade of breast density and bone density at base line and at 12 months; to assess overall safety (bone and lipid metabolism, toxicity); to compare menopause-specific quality of life. NCT Registration ID (from clinicaltrials.gov): NCT00066586 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 01, 2001 Closing Date: June 09, 2006	Permanently Closed
MAP3	A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer Read More Complexity Level: 3 Eligibility: Postmenopausal women at increased risk for the development of breast cancer are eligible for this study Objectives: To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo NCT Registration ID (from clinicaltrials.gov): NCT00083174 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 11, 2004 Closing Date: March 23, 2010	Permanently Closed
MAP3B	The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer - A Companion Study to MAP.3 Read More Complexity Level: 3 Eligibility: Woman randomized to MAP.3 with: a BMD of Spine (L1-L4)or Total Hip and Femoral Neck, T score >= -1.9 sd are eligible for this study. Objectives: To examine whether there is clinically relevant difference in impact on BMD between exemestane and placebo after two years from randomization to the core protocol. NCT Registration ID (from clinicaltrials.gov): NCT00688246 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 23, 2008 Closing Date: March 23, 2010	Permanently Closed
MAX1 (QMUL LATTE)	Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE) Read More Complexity Level: 3 Eligibility: Patients must satisfy the following criteria to be eligible for entry into this study: patients randomised to one of the monotherapy arms in the ATAC Trial alive at 10 years follow-up Objectives: Primary objectives The primary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment + 5 years follow-up) as adjuvant therapy in terms of: Time to recurrence of breast cancer in the post 10 year period (defined as the earliest of local or distant recurrence, new primary breast cancer, or death) Death after recurrence Secondary objectives The secondary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment) as adjuvant therapy in terms of: Time to distant recurrence Cancer-specific survival New breast primaries Other cancers Ischaemic cardiac and cerebrovascular events Hip (and other) fractures NCT Registration ID (from clinicaltrials.gov): NCT01745289 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 21, 2016 Closing Date: January 21, 2019	Permanently Closed

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