Palbociclib + Bicalutamide for Breast Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Ayca Gucalp, MD - MSK Breast Medical ...

Overseen byAyca Gucalp, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the safety and effectiveness of the investigational drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor positive breast cancer.

Eligibility Criteria

This trial is for postmenopausal women with AR(+) metastatic breast cancer who haven't been treated with bicalutamide or CDK4/6 inhibitors. Participants must have adequate organ function, not be pregnant, and agree to use contraception. They should have recovered from previous treatments and cannot have active severe illnesses or a history of certain heart conditions.

Inclusion Criteria

My tumor tests positive for androgen receptors.

My brain cancer has not worsened in the last 3 months.

I have never been treated with bicalutamide.

+17 more

Exclusion Criteria

You are currently taking any experimental cancer drugs.

You have had allergic reactions to drugs similar to palbociclib.

Pregnant women and women who are breast-feeding

+6 more

Participant Groups

The study tests the combination of palbociclib (an investigational drug) and bicalutamide in treating triple negative, AR(+) metastatic breast cancer. It aims to determine the safety and effectiveness of this treatment regimen.

1Treatment groups

Experimental Treatment

Group I: Palbociclib in Combination with BicalutamideExperimental Treatment2 Interventions

This is a non-randomized, open-label, phase I/II trial for patients with AR(+) MBC . There will be a dose finding phase I portion of the study to establish the recommended phase II dose (R2PD). This will be followed by a phase II where efficacy is evaluated. Patients with AR(+)ER(-) breast cancer treated on the phase I at the recommended phase II dose will be counted towards the primary endpoint analysis for the phase II study.

Bicalutamide is already approved in European Union, United States, Japan, Canada, Australia for the following indications:

🇪🇺 Approved in European Union as Casodex for: