Bicalutamide in Treating Patients With Metastatic Breast Cancer

NCT00468715 | Completed Phase 2 Results

• 2 other identifiers: 07-022MSKCC-07022
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 8

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• 6-month Response Rate (Complete Response, Partial Response, and Stable Disease)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  6 months

Secondary Outcomes (2)

• Count of Participants With Progression-free Survival

  1 year

• Number of Participants Evaluated for Toxicity

  1 year

Study Arms (1)

bicalutamide

EXPERIMENTAL

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

Interventions

bicalutamide DRUG

bicalutamide

diagnostic laboratory biomarker analysis OTHER

bicalutamide

immunohistochemistry staining method OTHER

bicalutamide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• AstraZeneca: collaborator

Study Sites (8)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, 10035, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

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

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

bicalutamide; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Results Point of Contact

• Title: Dr. Tiffany Traina
• Organization: Memorial Sloan Kettering Cancer Center

trainat@mskcc.org

646-888-4558

Study Officials

• Tiffany A. Traina, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 3, 2007
• Study Start: March 23, 2007
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: August 3, 2022
• Results First Posted: August 3, 2022

Record last verified: 2021-06

Locations

US (8)