Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066690
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2003-08-06
Brief Title:
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone 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 Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies 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:
SOFT
Brief Summary:
RATIONALE Estrogen can stimulate the growth of breast tumor cells Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer
PURPOSE This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer
PURPOSE This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for 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 tamoxifen ovarian function suppression by triptorelin oophorectomy or ovarian irradiation or exemestane ovarian function suppression vs tamoxifen alone The primary comparison is ovarian function suppression with either tamoxifen or exemestane vs tamoxifen alone
Compare the quality of life including late side effects of early menopause of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center prior adjuvantneoadjuvant chemotherapy yes vs no and number of positive axillary andor internal mammary lymph nodes 0 vs 1 or more and intended initial method of ovarian function suppression triptorelin vs oophorectomy vs ovarian irradiation 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 then annually for 4 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 tamoxifen ovarian function suppression by triptorelin oophorectomy or ovarian irradiation or exemestane ovarian function suppression vs tamoxifen alone The primary comparison is ovarian function suppression with either tamoxifen or exemestane vs tamoxifen alone
Compare the quality of life including late side effects of early menopause of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center prior adjuvantneoadjuvant chemotherapy yes vs no and number of positive axillary andor internal mammary lymph nodes 0 vs 1 or more and intended initial method of ovarian function suppression triptorelin vs oophorectomy vs ovarian irradiation 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 then annually for 4 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 |
|---|---|---|---|
| U24CA075362 | NIH | CTEP | httpsreporternihgovquickSearchU24CA075362 |
| NCI-2009-01086 | REGISTRY | None | None |
| CDR0000316456 | None | None | None |
| BIG 2-02 | None | None | None |
| 2004-000166-13 | None | None | None |
| IBCSG-24-02 | OTHER | None | None |