Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217659
Status:
WITHDRAWN
Last Update Posted:
2013-01-03
First Post:
2005-09-20
Brief Title:
S0511 Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0511 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |