I237

I237 Details
Status: Closed
Activation Date: 2018DEC21
Closing Date: 2023JAN17
Phase: II

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

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.

Objective: 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.

Participation: Limited to invited centres

Lay Description: The main purpose of this study is to determine the response to CFI-400945 in patients with advanced breast cancer, and to investigate disease control, safety and toxicity of CFI-400945 and the effects CFI-400945 has on cancer cells. Additional research will explore the relationship between certain genomic features and outcomes of treatment.

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Hide Tissue Samples

Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
IND	I237	76	24	66	69

Hide TMA Samples

(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
IND	I237	76	0	0

Hide Fluid Samples

Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
IND	I237	76	0	0	0	0	0	0	0	0