Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004125
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 It is not yet known which regimen of chemotherapy is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes
Detailed Description:
OBJECTIVES
Compare the disease-free survival and overall survival in patients with node-positive or high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel or paclitaxel after doxorubicin and cyclophosphamide
Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks improves disease-free survival and overall survival when compared with the conventional schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this patient population
Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12 weeks versus every 3 weeks for 4 courses in these patients
Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly for 12 weeks to that of docetaxel administered on the same schedules in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to estrogen receptor status positive vs negative vs unknown nodal status 0 positive nodes vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes tumor size no more than 5 cm vs more than 5 cm vs unknown and type of prior surgery mastectomy vs breast conservation surgery Patients are randomized to one of four treatment arms
Arm I Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4 courses weeks 1-12 Beginning at week 13 patients receive paclitaxel IV over 3 hours every 3 weeks for 4 courses
Arm II Patients receive doxorubicin and cyclophosphamide as in arm I Beginning at week 13 patients receive paclitaxel IV over 1 hour weekly for 12 weeks
Arm III Patients receive doxorubicin and cyclophosphamide as in arm I Beginning at week 13 patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses
Arm IV Patients receive doxorubicin and cyclophosphamide as in arm I Beginning at week 13 patients receive docetaxel IV over 1 hour weekly for 12 weeks
Within 4 weeks after completion of chemotherapy patients with estrogen andor progesterone receptor positive tumors receive oral tamoxifen daily for 5 years
After completion of all chemotherapy patients with prior segmental mastectomy receive radiotherapy once daily 5 days per week for 5-6 weeks Patients with prior modified radical mastectomy may receive radiotherapy after chemotherapy completion at the investigators discretion
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 5000 patients will be accrued for this study within 127 years
Compare the disease-free survival and overall survival in patients with node-positive or high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel or paclitaxel after doxorubicin and cyclophosphamide
Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks improves disease-free survival and overall survival when compared with the conventional schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this patient population
Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12 weeks versus every 3 weeks for 4 courses in these patients
Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly for 12 weeks to that of docetaxel administered on the same schedules in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to estrogen receptor status positive vs negative vs unknown nodal status 0 positive nodes vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes tumor size no more than 5 cm vs more than 5 cm vs unknown and type of prior surgery mastectomy vs breast conservation surgery Patients are randomized to one of four treatment arms
Arm I Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4 courses weeks 1-12 Beginning at week 13 patients receive paclitaxel IV over 3 hours every 3 weeks for 4 courses
Arm II Patients receive doxorubicin and cyclophosphamide as in arm I Beginning at week 13 patients receive paclitaxel IV over 1 hour weekly for 12 weeks
Arm III Patients receive doxorubicin and cyclophosphamide as in arm I Beginning at week 13 patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses
Arm IV Patients receive doxorubicin and cyclophosphamide as in arm I Beginning at week 13 patients receive docetaxel IV over 1 hour weekly for 12 weeks
Within 4 weeks after completion of chemotherapy patients with estrogen andor progesterone receptor positive tumors receive oral tamoxifen daily for 5 years
After completion of all chemotherapy patients with prior segmental mastectomy receive radiotherapy once daily 5 days per week for 5-6 weeks Patients with prior modified radical mastectomy may receive radiotherapy after chemotherapy completion at the investigators discretion
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 5000 patients will be accrued for this study within 127 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 |
|---|---|---|---|
| SWOG-E1199 | None | None | None |
| E1199 | None | None | None |
| CLB-49906 | None | None | None |
| NCCTG-E1199 | None | None | None |