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 goserelin together with anastrozole may be an effective treatment for
male breast cancer.
PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole
works in treating men with recurrent or metastatic breast cancer.
- Determine the progression-free survival (PFS) of men with estrogen receptor- or
progesterone receptor-positive recurrent or metastatic breast cancer treated with
goserelin and anastrozole.
- Determine the overall objective tumor response rate (confirmed and unconfirmed,
complete and partial) in patients with measurable disease treated with this regimen.
- Correlate prostate specific antigen (PSA), testosterone, estradiol, estrone, estrone
sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone
levels with PFS and response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28.
Treatment repeats every 28 days for up to 12 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed at approximately 4-6 weeks and
then every 3-6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90089-9181, United States
University of California Davis Cancer Center, Sacramento, California 95817, United States
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado 80045, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States
Montrose Memorial Hospital Cancer Center, Montrose, Colorado 81401, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado 80033, United States
Broward General Medical Center Cancer Center, Ft. Lauderdale, Florida 33316, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois 62781-0001, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas 66720, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas 67801, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas 67042, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States
Southwest Medical Center, Liberal, Kansas 67901, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas 67114, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas 67357, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas 67124, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas 67042, United States
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas 67401, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas 67152, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, United States
CCOP - Wichita, Wichita, Kansas 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan 48202, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65802, United States
St. John's Regional Health Center, Springfield, Missouri 65804, United States
Billings Clinic Cancer Center, Billings, Montana 59107-5100, United States
CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States
Deaconess Billings Clinic - Downtown, Billings, Montana 59107-7000, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana 59101, United States
Northern Rockies Radiation Oncology Center, Billings, Montana 59101, United States
St. Vincent Healthcare, Billings, Montana 59101, United States
Bozeman Deaconess Hospital, Bozeman, Montana 59715, United States
St. James Community Hospital, Butte, Montana 59701, United States
Great Falls, Montana 59405, United States
Great Falls Clinic, Great Falls, Montana 59405, United States
St. Peter's Hospital, Helena, Montana 59601, United States
Glacier Oncology, PLLC, Kalispell, Montana 59901, United States
Kalispell Medical Oncology, Kalispell, Montana 59901, United States
Kalispell Regional Medical Center, Kalispell, Montana 59901, United States
Community Medical Center, Missoula, Montana 59801, United States
Guardian Oncology and Center for Wellness, Missoula, Montana 59804, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana 59807, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana 59807-7877, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States
Rutherford Hospital, Rutherfordton, North Carolina 28139, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
Community Oncology Group at Cleveland Clinic Cancer Center, Independence, Ohio 44131, United States
Cleveland Clinic - Wooster, Wooster, Ohio 44691, United States
AnMed Health Cancer Center, Anderson, South Carolina 29621, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming 82801, United States