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Bicalutamide in Treating Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468715
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : June 29, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: bicalutamide Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2007
Actual Primary Completion Date : June 24, 2021
Actual Study Completion Date : June 24, 2021

Arm Intervention/treatment
Experimental: 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.
Drug: bicalutamide
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method

Primary Outcome Measures :
  1. 6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria for patients with measurable disease [ Time Frame: 6 months ]
  2. 6-month response rate (stable disease or progressive disease) as measured by RECIST criteria for patients with non-measurable disease [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Median progression-free survival [ Time Frame: 1 year ]
  2. Safety [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468715

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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States, 10035
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Tiffany A. Traina, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00468715    
Other Study ID Numbers: 07-022
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage IV breast cancer
recurrent breast cancer
male breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents