Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2003-08-06
Brief Title:
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
TEXT
Brief Summary:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Hormone therapy using triptorelin exemestane and tamoxifen may fight breast cancer by blocking the use of estrogen It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer
PURPOSE This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer
PURPOSE This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer
Detailed Description:
OBJECTIVES
Compare the disease-free survival breast cancer-free interval distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen
Compare the quality of life including late side effects of early menopause of patients treated with these regimens
OUTLINE This is a randomized international multicenter study Patients are stratified according to planned use of concurrent adjuvant chemotherapy yes vs no and number of positive lymph nodes 0 vs 1 or more Treatment duration is 5 years Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter Quality of life is assessed at baseline every 6 months for 2 years and annually for 3 years
Compare the disease-free survival breast cancer-free interval distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen
Compare the quality of life including late side effects of early menopause of patients treated with these regimens
OUTLINE This is a randomized international multicenter study Patients are stratified according to planned use of concurrent adjuvant chemotherapy yes vs no and number of positive lymph nodes 0 vs 1 or more Treatment duration is 5 years Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter Quality of life is assessed at baseline every 6 months for 2 years and annually for 3 years
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 |
|---|---|---|---|
| CDR0000316458 | REGISTRY | CTgov | None |
| IBCSG 25-02 | None | None | None |
| BIG 3-02 | OTHER | None | None |
| NABCI IBCSG 25-02 | None | None | None |
| EU-20347 | None | None | None |
| 2004-000168-28 | EUDRACT_NUMBER | None | None |