S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00217659|
Recruitment Status : Withdrawn (poor accrual)
First Posted : September 22, 2005
Last Update Posted : January 3, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anastrozole Drug: goserelin acetate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
U.S. FDA Resources
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217659
Show 57 Study Locations
|OverallOfficial:||Zeina Nahleh, MD||Barrett Cancer Center|
|OverallOfficial:||Abdul-Rahman Jazieh, MD, MPH||Barrett Cancer Center|
|OverallOfficial:||Robert B. Livingston, MD||University of Washington|
|OverallOfficial:||Gabriel N. Hortobagyi, MD, FACP||M.D. Anderson Cancer Center|