Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003782
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Women With Stage I Stage II or Stage IIIA cT1-3 N0-1 M0 Breast Cancer and Positive Axillary Lymph Nodes
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Three-Arm Randomized Trial to Compare Adjuvant Adriamycin and Cyclophosphamide Followed by Taxotere AC-T Adriamycin and Taxotere AT and Adriamycin Taxotere and Cyclophosphamide ATC in Breast Cancer Patients With Positive Axillary Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2024-03
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I stage II or stage IIIA breast cancer with positive axillary lymph nodes
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I stage II or stage IIIA breast cancer with positive axillary lymph nodes
Detailed Description:
OBJECTIVES
Compare the efficacy of adjuvant doxorubicin cyclophosphamide and docetaxel given concurrently vs adjuvant doxorubicin and cyclophosphamide followed by docetaxel in terms of overall survival and disease-free survival of women with breast cancer and positive axillary lymph nodes
Compare the efficacy of adjuvant doxorubicin and docetaxel vs regimens containing cyclophosphamide in these patients
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens Quality of life substudy closed to accrual as of 72001
Compare the differences in amenorrhea in premenopausal women in each treatment arm and its relationship to symptoms quality of life quality of life substudy closed to accrual as of 72001 disease-free survival and overall survival
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center number of positive nodes 1-3 vs 4-9 vs at least 10 sequential tamoxifen or anastrozole administration yes vs no and type of prior surgery and radiotherapy plan mastectomy with no local or regional radiotherapy vs mastectomy with local andor regional radiotherapy vs lumpectomy with local radiotherapy vs lumpectomy with local and regional radiotherapy Patients are randomized to one of three treatment arms
Arm 1 Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes every 21 days for 4 courses Three weeks after the last dose of this combination patients receive docetaxel IV over 1 hour every 21 days for 4 courses
Arm 2 Patients receive doxorubicin IV over 15 minutes and docetaxel IV over 1 hour every 21 days for 4 courses
Arm 3 Patients receive doxorubicin IV over 15 minutes cyclophosphamide IV over 30 minutes and docetaxel IV over 1 hour every 21 days for 4 courses
Patients in all arms who are estrogen receptor-positive andor progesterone receptor-positive receive oral tamoxifen daily for 5 years beginning within 3-12 weeks of completion of chemotherapy Patients who are postmenopausal may receive alternative hormonal therapy at the discretion of the treating physician
Some patients may receive postmastectomy radiotherapy on SWOG-S9927 or NCIC-MA20 after recovery from chemotherapy
Quality of life and menstrual history are assessed before randomization on day 1 of course 4 and at 6 12 18 and 24 months Quality of life substudy closed to accrual as of 72001
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 5300 patients will be accrued for this study within 4-5 years
Compare the efficacy of adjuvant doxorubicin cyclophosphamide and docetaxel given concurrently vs adjuvant doxorubicin and cyclophosphamide followed by docetaxel in terms of overall survival and disease-free survival of women with breast cancer and positive axillary lymph nodes
Compare the efficacy of adjuvant doxorubicin and docetaxel vs regimens containing cyclophosphamide in these patients
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens Quality of life substudy closed to accrual as of 72001
Compare the differences in amenorrhea in premenopausal women in each treatment arm and its relationship to symptoms quality of life quality of life substudy closed to accrual as of 72001 disease-free survival and overall survival
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center number of positive nodes 1-3 vs 4-9 vs at least 10 sequential tamoxifen or anastrozole administration yes vs no and type of prior surgery and radiotherapy plan mastectomy with no local or regional radiotherapy vs mastectomy with local andor regional radiotherapy vs lumpectomy with local radiotherapy vs lumpectomy with local and regional radiotherapy Patients are randomized to one of three treatment arms
Arm 1 Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes every 21 days for 4 courses Three weeks after the last dose of this combination patients receive docetaxel IV over 1 hour every 21 days for 4 courses
Arm 2 Patients receive doxorubicin IV over 15 minutes and docetaxel IV over 1 hour every 21 days for 4 courses
Arm 3 Patients receive doxorubicin IV over 15 minutes cyclophosphamide IV over 30 minutes and docetaxel IV over 1 hour every 21 days for 4 courses
Patients in all arms who are estrogen receptor-positive andor progesterone receptor-positive receive oral tamoxifen daily for 5 years beginning within 3-12 weeks of completion of chemotherapy Patients who are postmenopausal may receive alternative hormonal therapy at the discretion of the treating physician
Some patients may receive postmastectomy radiotherapy on SWOG-S9927 or NCIC-MA20 after recovery from chemotherapy
Quality of life and menstrual history are assessed before randomization on day 1 of course 4 and at 6 12 18 and 24 months Quality of life substudy closed to accrual as of 72001
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 5300 patients will be accrued for this study within 4-5 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 |
|---|---|---|---|
| CDR0000066914 | None | None | None |