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
- Determine the 6-month efficacy rate of bicalutamide as first-, second-, or third-line
therapy in patients with androgen receptor-positive and estrogen receptor- and
progesterone receptor-negative metastatic breast cancer.
- Determine the 6-month progression-free survival of patients treated with this drug.
- Evaluate the safety of this drug in these patients.
- Evaluate changes in estradiol, total and free testosterone, and sex-hormone binding
globulin in response to androgen blockade in patients treated with this drug.
- Evaluate tissue, including cytokeratins 5/6 and 17, SPDEF, ALCAM, ERBB2, FGFR4, and
prostate-specific antigen (PSA), using immunohistochemical analysis in patients treated
with this drug.
OUTLINE: This is a open-label study.
Patients receive oral bicalutamide once daily for 4 weeks. Treatment repeats every 4 weeks
for 6 months in the absence of disease progression or unacceptable toxicity. Patients
achieving complete response, partial response, or stable disease may continue to receive
bicalutamide as above at the discretion of the investigator.
Patients undergo blood and tissue sample collection for correlative studies. Samples are
analyzed for hormonal levels, including estradiol, total testosterone, free testosterone,
and sex-hormone binding globulin, and proteins, including ALCAM, SPEDF, and CK 5/6, by
immunohistochemical analysis at baseline, after course 1, and at the end of the study.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria for patients with measurable disease
Tiffany A. Traina, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Duke Cancer Institute||Durham, North Carolina 27710|
|Ralph Lauren Center for Cancer Care and Prevention||New York, New York 10035|