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A Phase II Study of Bicalutamide for the Treatment of Androgen-Receptor-Positive, Estrogen- and Progesterone-Receptor-Negative Metastatic Breast Cancer

[Protocol 07-022]

Full Title :
BICALUTAMIDE FOR THE TREATMENT OF ANDROGEN RECEPTOR POSITIVE((AR+), ESTROGEN RECEPTOR NEGATIVE, PROGESTERONE RECEPTOR NEGATIVE (ER-/PR-)METASTATIC BREAST CANCER PATIENTS: A PHASE II FEASIBILITY STUDY
Purpose :

Most breast cancers are sensitive to changes in the amount of estrogen in the body. Hormonal therapies that block estrogen can stop those types of cancer from growing. Some breast cancers do not respond to these hormonal treatments because they lack the receptors for estrogen and progesterone. Some of these estrogen and progesterone receptor-negative cancers do, however, contain a protein called the androgen receptor, and behave like estrogen-sensitive cancers.

Studies show that blocking the androgen receptor can slow the growth of breast cancer cells that contain this protein. Bicalutamide is a drug that works by blocking the androgen receptor. It is commonly used to treat prostate cancer, but has not been evaluated in patients with hormone receptor-negative, androgen receptor-positive breast cancer.

The purpose of this study is to assess the effectiveness of bicalutamide to treat metastatic breast cancer that contains the androgen receptor but not the receptors for estrogen and progesterone.

Eligibility :

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

  • Patients must have a confirmed diagnosis of metastatic (stage IV) breast cancer that contains the androgen receptor but not the receptors for estrogen and progesterone.
  • Patients may have had up to two prior regimens of chemotherapy for metastatic disease. At least 2 weeks must have passed since completion of any prior chemotherapy and 4 weeks since any major surgery and entry into the study.
  • 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.
  • Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. Cliff Hudis at 646-888-4551.

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