A Phase I/II Study of Palbociclib plus Bicalutamide to Treat Advanced Breast Cancer Containing the Androgen Receptor

Full Title

Phase I/II Trial of Palbociclib in Combination with Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)

Purpose

Palbociclib is a drug approved to treat metastatic breast cancer that is fueled by estrogen. In this study, researchers are seeking to find the highest dose of palbociclib that can be given with the drug bicalutamide in women with metastatic breast cancer that contains a protein called the androgen receptor. The use of palbociclib in this study is considered investigational.

The androgen receptor is involved in the growth of prostate cancers as well as some breast cancers, and bicalutamide works by blocking its activity. Palbociclib blocks the activity of two enzymes (CDK4 and CDK6) that are involved in the growth of some breast cancers. It is hoped that giving palbociclib and bicalutamide together will shrink tumors in women with metastatic breast cancers that contain the androgen receptor.

Both palbociclib and bicalutamide are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • The phase I portion of the study is for women with estrogen-receptor positive breast cancer or triple-negative breast cancer (breast cancer which does not contain receptors for estrogen, progesterone, or HER2) that contains the androgen receptor. The phase II portion is only for women with triple-negative breast cancer that contains the androgen receptor.
  • At least 2 weeks must pass between the completion of prior therapies (3 weeks since any major surgery) and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ayca Gucalp at 646-888-4538.

Protocol

15-207

Phase

I/II

Investigator

Co-Investigators

Diseases