Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002529
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
1999-11-01
Brief Title:
Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
Adjuvant Therapy for PostPerimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone
Status:
COMPLETED
Status Verified Date:
2012-07
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:
12-93
Brief Summary:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Hormone therapy may fight breast cancer by blocking the uptake of estrogen Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with hormone therapy may kill more tumor cells It is not yet known which treatment regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of hormone therapy during or after combination chemotherapy or hormone therapy alone in treating perimenopausal or postmenopausal women who have stage II or stage IIIA breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of hormone therapy during or after combination chemotherapy or hormone therapy alone in treating perimenopausal or postmenopausal women who have stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES I Compare overall survival and local and systemic disease-free survival produced by adjuvant chemoendocrine therapy with 4 courses of anthracyclinecyclophosphamide and concurrent vs sequential tamoxifen TMX or toremifene TOR in peri- and postmenopausal women with node-positive breast cancer who are considered suitable for endocrine therapy alone II Evaluate these same endpoints in patients randomized to chemoendocrine therapy vs endocrine therapy alone III Evaluate these same endpoints in patients randomized to TMX vs TOR as the endocrine therapy agent IV Compare the quality of life of patients treated on these regimens V Compare the toxic effects of these regimens
OUTLINE This is a randomized study Patients are stratified by type of primary therapy and participating institution Therapy must begin within 6 weeks of surgery Patients in the first group receive doxorubicin or epirubicin and cyclophosphamide every 28 days for a total of 4 cycles and oral tamoxifen daily for 5 years beginning day 1 of chemotherapy Patients in the second group receive the same chemotherapy with oral tamoxifen initiated on day 8 of the fourth chemotherapy cycle and continued for 5 years Patients in the third group receive oral tamoxifen daily for 5 years Patients in the fourth group are treated the same as the first group only tamoxifen is replaced by toremifene Patients in the fifth group are treated the same as the second group only tamoxifen is replaced by toremifene Patients in the sixth group receive oral toremifene daily for 5 years The timing of optional radiotherapy for patients with less than total mastectomy in each group is based on institutional policy radiotherapy is administered for 5-6 weeks to the remaining breast tissue chest wall and lung Patients are followed every 3 months for 1 year every 6 months for 2 years and yearly thereafter
PROJECTED ACCRUAL 1140 patients will be accrued over approximately 9 years with 1 additional year of follow-up
OUTLINE This is a randomized study Patients are stratified by type of primary therapy and participating institution Therapy must begin within 6 weeks of surgery Patients in the first group receive doxorubicin or epirubicin and cyclophosphamide every 28 days for a total of 4 cycles and oral tamoxifen daily for 5 years beginning day 1 of chemotherapy Patients in the second group receive the same chemotherapy with oral tamoxifen initiated on day 8 of the fourth chemotherapy cycle and continued for 5 years Patients in the third group receive oral tamoxifen daily for 5 years Patients in the fourth group are treated the same as the first group only tamoxifen is replaced by toremifene Patients in the fifth group are treated the same as the second group only tamoxifen is replaced by toremifene Patients in the sixth group receive oral toremifene daily for 5 years The timing of optional radiotherapy for patients with less than total mastectomy in each group is based on institutional policy radiotherapy is administered for 5-6 weeks to the remaining breast tissue chest wall and lung Patients are followed every 3 months for 1 year every 6 months for 2 years and yearly thereafter
PROJECTED ACCRUAL 1140 patients will be accrued over approximately 9 years with 1 additional year of follow-up
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-F93-0010 | Other Identifier | International Breast Cancer Study Group | None |
| IBCSG-12-93 | OTHER | None | None |
| EU-93015 | None | None | None |