Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004205
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2000-01-21
Brief Title:
Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor ER andor PgR Positive Tumors
Status:
COMPLETED
Status Verified Date:
2017-12
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:
BIG 1-98
Brief Summary:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells If is not yet known which treatment regimen is most effective for breast cancer
PURPOSE Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed
PURPOSE Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed
Detailed Description:
OBJECTIVES
Compare adjuvant letrozole vs tamoxifen administered for 5 years in postmenopausal women with operable hormone receptor-positive breast cancer
Compare these treatment regimens given sequentially vs continuously in this patient population
Compare these treatment regimens in terms of overall survival disease-free and systemic-free survival safety and tolerability in this patient population
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to adjuvant chemotherapy prior therapy vs no prior or concurrent therapy vs concurrent therapy prior surgery modified radical mastectomy vs a lesser surgical procedure and participating center Patients are randomized to one of four treatment arms
Arm I Patients receive adjuvant oral tamoxifen daily for 5 years
Arm II Patients receive adjuvant oral letrozole daily for 5 years
Arm III Patients receive adjuvant oral tamoxifen daily for 2 years followed by adjuvant oral letrozole daily for 3 years
Arm IV Patients receive adjuvant oral letrozole daily for 2 years followed by adjuvant oral tamoxifen daily for 3 years
Patients may receive concurrent radiotherapy Some patients receive concurrent adjuvant chemotherapy beginning within 8 weeks after surgery and continuing for no more than 6 months
Patients are followed annually
PROJECTED ACCRUAL A total of 5180 patients 1295 per treatment arm will be accrued for this study within 6 years
Compare adjuvant letrozole vs tamoxifen administered for 5 years in postmenopausal women with operable hormone receptor-positive breast cancer
Compare these treatment regimens given sequentially vs continuously in this patient population
Compare these treatment regimens in terms of overall survival disease-free and systemic-free survival safety and tolerability in this patient population
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to adjuvant chemotherapy prior therapy vs no prior or concurrent therapy vs concurrent therapy prior surgery modified radical mastectomy vs a lesser surgical procedure and participating center Patients are randomized to one of four treatment arms
Arm I Patients receive adjuvant oral tamoxifen daily for 5 years
Arm II Patients receive adjuvant oral letrozole daily for 5 years
Arm III Patients receive adjuvant oral tamoxifen daily for 2 years followed by adjuvant oral letrozole daily for 3 years
Arm IV Patients receive adjuvant oral letrozole daily for 2 years followed by adjuvant oral tamoxifen daily for 3 years
Patients may receive concurrent radiotherapy Some patients receive concurrent adjuvant chemotherapy beginning within 8 weeks after surgery and continuing for no more than 6 months
Patients are followed annually
PROJECTED ACCRUAL A total of 5180 patients 1295 per treatment arm will be accrued for this study within 6 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 |
|---|---|---|---|
| BIG-1-98 | None | None | None |
| IBCSG-18-98 | None | None | None |
| DAN-DBCG-IBCSG-1-98 | None | None | None |
| FRE-FNCLCC-IBCSG-1-98 | None | None | None |
| EU-99022 | None | None | None |
| NOVARTIS-2026703019 | None | None | None |