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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00468715 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: bicalutamide Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 28 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
No active brain metastases or leptomeningeal disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Clifford A. Hudis, MD 646-888-4551 | |
Ralph Lauren Center for Cancer Care and Prevention | Recruiting |
New York, New York, United States, 10035 | |
Contact: Joseph P. Yoe, MD 212-987-1777 |
Principal Investigator: | Clifford A. Hudis, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Tiffany A. Traina, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Clifford A. Hudis ) |
Study ID Numbers: | CDR0000542434, MSKCC-07022 |
Study First Received: | May 2, 2007 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00468715 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer male breast cancer |
Estrogens Skin Diseases Progesterone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Breast Cancer, Male |
Hormones Recurrence Androgen Antagonists Breast Neoplasms, Male Bicalutamide Breast Diseases Androgens |
Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Bicalutamide Breast Diseases |