Wednesday, April 20, 2022 BR36 : "A Biomarker-Directed, Open Label, Multi-Centre Phase II Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients with Non-Small Cell Lung Cancer" has closed to accrual after reaching its accrual target for stage 1. Although accrual is now closed to this study, follow up of patients will continue according to the protocol. Objectives: Primary: Identify optimal time points for molecular response as assessed by ctDNA assay and validate concordance of molecular response with radiologic response. Secondary: evaluate time to molecular response, correlate molecular response to RECIST response, PFS and OS,to explore degree of ctDNA reduction with clinical outcomes. Tertiary: collect archival tumour tissue for translational research studies. For more information please visit the CCTG BR36 members trial page. IND236 : "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" was closed to accrual after reaching its Stage I accrual target. The minimum required responses were not reached and the trial will not proceed to Stage II. Although accrual is now closed to this study, follow up of patients will continue according to the protocol. 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. For more information please visit the CCTG IND236 members trial page.
