Breast Cancer Clinical Trial
Official title:
A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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