Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancermale 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: bicalutamideOther: diagnostic laboratory biomarker analysisOther: immunohistochemistry staining method

Interventions

bicalutamideDrug

bicalutamide

diagnostic laboratory biomarker analysisOther

bicalutamide

immunohistochemistry staining method

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead
AstraZeneca
Industrycollaborator
National Cancer Institute (NCI)

Study Sites (8)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

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

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

Boston, Massachusetts, 02115, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, 10035, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

bicalutamideImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and Procedures

Results Point of Contact

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

Study Officials

Tiffany A. Traina, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Bicalutamide in Treating Patients With Metastatic Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

bicalutamide

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

bicalutamide

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations