S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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 anastrozole. Determine the overall survival of patients treated with this regimen. 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. Determine the toxicity of this regimen in these patients. 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.

Official Title
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A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: anastrozole
* Drug: goserelin acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: anastrozole|nan|
|Drug: goserelin acetate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  |  | 
| Overall survival |  |  | 
| Overall objective tumor response rate (confirmed and unconfirmed, complete and partial) |  |  | 
| Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male breast cancer, recurrent breast cancer, stage IV breast cancer