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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 (OFSET)

Testing the addition of chemotherapy to the usual treatment of ovarian function suppression plus hormonal therapy in premenopausal ER-positive/HER2-negative breast cancer patients who are at high risk of cancer returning


Complexity Level: 2

Eligibility: Female patients must be ≥ 18 years of age and premenopausal. May have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria. May have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. Must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND). Primary tumor must be pT1-3. (If N0, must be T1c or higher.). Ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c). Must be ER/PR postiive and HER2 negative.

Objectives: To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

NCT Registration ID (from clinicaltrials.gov): NCT05879926
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: August 28, 2024

Chair: (Canada) Dr. Jean-Pierre Ayoub, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 20692


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


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: Yes
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
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.


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
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.


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
MAC26 (SWOG S1706)

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer


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: Closed to Accrual
Activation Date: May 28, 2019 Closing Date: July 01, 2024

Chair: (Canada) Dr. Eileen Rakovitch, Odette Cancer Centre, (416) 480-4974


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


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
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


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
MAC23 (ALLIANCE A221505)

RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction


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
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.


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
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


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
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


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
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


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
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.


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
MAC12 (ECOG PACCT-1)

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial


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

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.


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

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


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
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


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
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)


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
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)


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: Closed to Accrual
Activation Date: December 01, 2020 Closing Date: May 07, 2024

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752


Closed 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.


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
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


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
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


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

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


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
MA33 (TROG 0701)

A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast


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
MA32D (ALLIANCE A211201)

Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32


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
MA9C (8854)

Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients


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
MA7A

Phase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer


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
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.


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
I241B

A Phase II Study of RP-6306 in Patients with CDK4/6-Inhibitor Treated ER+HER2- Metastatic Breast Cancer Receiving Gemcitabine


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: Closed to Accrual
Activation Date: January 27, 2023 Closing Date: September 10, 2024

Chair: (Canada) Dr. John Hilton, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75086


Closed 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.


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
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.


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
I239

A Phase II Study of CFI-400945 and Durvalumab in Patients with Advanced/Metastatic Triple Negative Breast Cancer (TNBC)


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
I237

A Phase II Study of CFI-400945 in Patients with Advanced/Metastatic Breast Cancer


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
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


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