Status:
COMPLETED
Bicalutamide in Treating Patients With Metastatic Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 studyin...
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 progesteron...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 23 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00468715
Start Date
March 23 2007
End Date
June 24 2021
Last Update
August 3 2022
Active Locations (8)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
3
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905