Wednesday, January 23, 2019 IND237 "A Phase II Study of CFI-400945 in Patients with Advanced/Metastatic Breast Cancer" has been centrally activated. 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. For more information visit the CCTG IND.237 trial page BL13 "A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer" has been centrally activated. Objectives: The overall objective of this phase II randomized trial is to determine if Durvalumab when used in combination following standard trimodality therapy improves disease-free-survival in patients with muscle-invasive bladder cancer who are electing for bladder-sparing treatment. NCT Registration ID (from clinicaltrials.gov): NCT03768570 For more information visit the CCTG BL.13 trial page
