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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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



- 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.

Inclusion Criteria


- 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

- 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

- No concurrent trastuzumab (Herceptin®)

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month response rate (complete response, partial response, and stable disease) as measured by RECIST criteria for patients with measurable disease

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Tiffany A. Traina, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston, Massachusetts  02115
Duke Cancer Institute Durham, North Carolina  27710
Ralph Lauren Center for Cancer Care and Prevention New York, New York  10035