Bicalutamide in Treating Patients With Metastatic Breast Cancer

NCT ID: NCT00468715

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-23
• Study Completion Date: 2021-06-24

Brief 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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bicalutamide

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.

Group Type: EXPERIMENTAL

bicalutamide

Intervention Type: DRUG

diagnostic laboratory biomarker analysis

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

Interventions

bicalutamide

Intervention Type: DRUG

diagnostic laboratory biomarker analysis

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffany A. Traina, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Duke Cancer Institute

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

MSKCC-07022

Identifier Type: -

Identifier Source: secondary_id

07-022

Identifier Type: -

Identifier Source: org_study_id