CFI-400945 + Durvalumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to find out the effect that CFI-400945 and durvalumab have on breast cancer.

Eligibility Criteria

This trial is for women with advanced or unresectable triple negative breast cancer, which means their tumors lack receptors for estrogen, progesterone, and HER2. Participants need to have a specific tissue block available and must be able to provide consent. They should have documented disease progression and be over 18 years old with good performance status (able to carry out daily activities).

Inclusion Criteria

I am a female patient.

I have a tissue sample from my cancer and agreed to its use in research.

My disease is confirmed by tests done within the last 3 weeks.

+7 more

Participant Groups

The study is testing the effects of two drugs on breast cancer: CFI-400945, an experimental drug, and Durvalumab, an immunotherapy drug. The goal is to see how these treatments impact the progression of advanced triple negative breast cancer.

1Treatment groups

Experimental Treatment

Group I: CFI-400945 + DurvalumabExperimental Treatment2 Interventions

CFI-400945 32 mg orally on Days 1-7 and Days 15-21 of Cycle 1 (28 day cycle) and then daily from Cycle 2 on and Durvalumab 1500mg IV on Day 1 (28 day cycles) from Cycle 2 on.