Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

• 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.

Secondary

• 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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Stage IV disease

• Measurable or non-measurable disease

• Patients with HER2/neu-positive disease must have received prior trastuzumab (Herceptin®)

• No active brain metastases or leptomeningeal disease

• History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain

• Hormone receptor status:

• Estrogen receptor- and progesterone receptor-negative*

• Androgen receptor-positive* NOTE: *Samples are considered positive if greater than 10% of cell nuclei are immunoreactive

PATIENT CHARACTERISTICS:

• Male or female

• Menopausal status not specified

• ECOG performance status 0-1

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the absence of liver metastases)

• Creatinine ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No serious medical or psychiatric illness

• No serious active infection

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No hypersensitivity reaction to bicalutamide or any of the tablet's components

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior cytotoxic chemotherapy and recovered

• At least 3 weeks since prior investigational drugs

• At least 4 weeks since prior major surgery and recovered

• Prior neoadjuvant or adjuvant chemotherapy allowed

• Any number of chemotherapy regimens are allowed for metastatic disease

• Prior hormonal therapy allowed

• No concurrent chemotherapy, other hormonal therapy, immunotherapy, or biological therapy

• No concurrent trastuzumab (Herceptin®)

• No concurrent enrollment in another clinical trial in which investigational procedures are performed or investigational therapies are administered

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Clifford A. Hudis

Tiffany A. Traina

Principal Investigator

U.S.A.
California
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensi	Ph: 877-827-3222
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph: 202-444-0381
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Sara Tolaney	Ph: 617-632-3474
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph: 507-538-7623
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Tiffany A. Traina	Ph: 212-639-5209
	Ralph Lauren Center for Cancer Care and Prevention
		Joseph P. Yoe, MD	Ph: 212-987-1777
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Cente	Ph: 877-668-0683; 919-966-4432
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph: 888-275-3853

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00468715
Information obtained from ClinicalTrials.gov on February 06, 2012

Back to Top