NCT00217659

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	anastrozole
DRUG	goserelin acetate

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-22
• Last updated: 2013-01-03

Locations

57 sites across 1 country: United States