Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010010
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2001-02-02
Brief Title:
Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase II Study of the Combination of Exemestane and Goserelin in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Hormone therapy using exemestane plus goserelin may fight breast cancer by reducing the production of estrogen
PURPOSE Phase II trial to study the effectiveness of exemestane and goserelin in treating premenopausal women who have metastatic breast cancer that has not responded to previous tamoxifen
PURPOSE Phase II trial to study the effectiveness of exemestane and goserelin in treating premenopausal women who have metastatic breast cancer that has not responded to previous tamoxifen
Detailed Description:
OBJECTIVES I Determine the efficacy of exemestane and goserelin in premenopausal women with hormone receptor positive metastatic breast cancer after tamoxifen failure II Determine the toxicity of this regimen in these patients III Determine the hormonal profile of patients treated with this regimen IV Determine the predictive value of HER-2 epidermal growth factor receptor and estrogen receptor for response in patients treated with this regimen
OUTLINE Patients receive oral exemestane daily on days 1-28 and goserelin subcutaneously on day 1 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 22-40 patients will be accrued for this study
OUTLINE Patients receive oral exemestane daily on days 1-28 and goserelin subcutaneously on day 1 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 22-40 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1906 | None | None | None |
| NYU-0004 | None | None | None |
| P-UPJOHN-NYU-0004 | None | None | None |