A Feasibility Study of Enzalutamide to Treat Early-Stage Androgen Receptor-Positive Triple-Negative Breast Cancer

Full Title

Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR(+) Triple Negative Breast Cancer

Purpose

Triple-negative breast cancers do not respond to treatments that target receptors for estrogen, progesterone, or the HER2 protein. Some triple-negative breast cancers, however, contain the androgen receptor. Laboratory studies show that blocking the androgen receptor can slow the growth of breast cancer cells containing this protein.

Enzalutamide is a drug use to treat advanced prostate cancer that works by blocking the androgen receptor. In this study, researchers want to see if patients with androgen receptor-positive triple-negative early-stage breast cancer tolerate enzalutamide well when they take it for up to one year. Their quality of life will be assessed while on treatment. Enzalutamide is a capsule that is taken orally (by mouth).

Eligibility

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

  • Patients must have stage I-III androgen receptor-positive, triple-negative breast cancer.
  • Patients may have had, but are not required to have had, prior chemotherapy.
  • At least 4 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must begin the study therapy within 6 months of completing their planned standard of care treatment (surgery, chemotherapy, and/or radiation therapy).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-5209.

Protocol

15-307

Phase

II

Investigator

Co-Investigators

Diseases