Status:
WITHDRAWN
S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving gose...
Detailed Description
OBJECTIVES: * Determine the progression-free survival (PFS) of men with estrogen receptor- or progesterone receptor-positive recurrent or metastatic breast cancer treated with goserelin and anastrozo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast cancer
- Recurrent or metastatic (stage IV) disease
- Patients with a local regional recurrence, including axillary and/or chest wall involvement, are eligible
- Measurable or non-measurable disease
- Brain metastases allowed provided they have been treated with surgery or radiotherapy AND have remained stable for ≥ 3 months
- Hormone receptor status:
- Estrogen receptor- OR progesterone receptor- positive disease by standard immunohistochemical techniques
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Male
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- No evidence of severe or uncontrolled hepatic disease
- Renal
- No evidence of severe or uncontrolled renal disease
- Cardiovascular
- No evidence of severe or uncontrolled cardiac disease
- Pulmonary
- No evidence of severe or uncontrolled respiratory disease
- Other
- Fertile patients must use effective barrier-method contraception during and for 12 weeks after the completion of study treatment
- No known HIV positivity
- Able to receive oral medication
- Patients with a gastrointestinal tube are eligible
- No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH agonist analogues, or any components of the study drugs
- No active infection requiring systemic therapy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
- No evidence of other severe or uncontrolled systemic disease
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors
- Chemotherapy
- At least 14 days since prior chemotherapy for this cancer and recovered
- No more than 1 prior chemotherapy regimen for metastatic disease
- No concurrent chemotherapy
- Endocrine therapy
- At least 14 days since prior hormonal therapy for this cancer and recovered
- Prior tamoxifen allowed
- No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or fulvestrant
- No other concurrent hormonal therapy (e.g., estrogen-based therapies)
- Radiotherapy
- See Disease Characteristics
- At least 14 days since prior radiotherapy for this cancer and recovered
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00217659
Start Date
September 1 2005
End Date
January 1 2007
Last Update
January 3 2013
Active Locations (57)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
University of California Davis Cancer Center
Sacramento, California, United States, 95817
3
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
4
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220