Bicalutamide in Treating Patients With Metastatic Breast Cancer
RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such as bicalutamide, may stop the adrenal glands from making androgens.
PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients with metastatic breast cancer.
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- 6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria for patients with measurable disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 6-month response rate (stable disease or progressive disease) as measured by RECIST criteria for patients with non-measurable disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Median progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
|Drug: bicalutamide Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method|
- 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.
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Ralph Lauren Center for Cancer Care and Prevention|
|New York, New York, United States, 10035|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Tiffany A. Traina, MD||Memorial Sloan-Kettering Cancer Center|