Immunotherapy with CFI-400945 for Breast Cancer

Recruiting in Palo Alto (17 mi)

+5 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

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called CFI-400945 for breast cancer patients who have already had chemotherapy. The drug works by blocking a protein that helps cancer cells grow, potentially slowing down or killing the cancer cells.

Eligibility Criteria

This trial is for female patients over 18 with advanced/metastatic breast cancer who've had chemotherapy including anthracycline and taxane. They must be able to swallow pills, have no serious illnesses that could interfere with the study, and not be pregnant or breastfeeding. Participants need a life expectancy of at least 3 months, adequate organ function, and must agree to use contraception.

Inclusion Criteria

Patients must be willing to use a Pillsy medication event monitoring system

I have given permission for my tissue sample to be used for research.

Patients must have a life expectancy of 3 months or longer

+17 more

Exclusion Criteria

I do not have any serious illnesses or infections that would prevent me from following the study's requirements.

I have had cancer before, but it was either skin cancer treated fully, cervical cancer treated without spreading, or any cancer treated over 2 years ago with no current signs of disease.

I have not used growth factors in the last 28 days and won't need them during the trial.

+8 more

Participant Groups

The trial tests CFI-400945 in women who have already undergone chemotherapy for breast cancer. It aims to see if this oral medication can further slow disease progression compared to standard treatments. Patients will use a Pillsy system for monitoring pill intake.

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Not PTEN-null, ER+ and/or PR+, HER2-Experimental Treatment1 Intervention

N=9 to 24 patients

Group II: Cohort 2: PTEN-null, ER+ and/or PR+, HER2-Experimental Treatment1 Intervention

N=9 to 24 patients

Group III: Cohort 1: TNBCExperimental Treatment1 Intervention

N=9 to 24 patients