Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003519
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Women With Breast Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Study of AdriamycinTaxotere Versus AdriamycinCytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative 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 Combining more than one drug may kill more tumor cells It is not yet known which combination chemotherapy regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor
Detailed Description:
OBJECTIVES I Determine whether doxorubicindocetaxel DD will improve disease-free survival and overall survival when compared to doxorubicincyclophosphamide DC in women with lymph node positive 1-3 positive nodes or high risk lymph node negative breast cancer II Compare the toxicity of DD to DC in this patient population
OUTLINE This is a randomized study Patients are stratified by node status positive vs negative menopause status pre- vs post estrogen receptor ER statusprogesterone receptor PR status ERPR unknown vs ERPR vs ERPR- vs ER-PR vs ER-PR- Patients in arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment courses Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for 4 treatment courses All patients who are estrogen receptor or progesterone receptor positive receive oral tamoxifen daily for 5 years following chemotherapy Some patients may also receive radiotherapy following chemotherapy Patients are followed every 3 months if patient is less than 2 years from study entry every 6 months if patient is 2-5 years from study entry and every 12 months if patient is greater than 5 years from study entry
PROJECTED ACCRUAL Approximately 2778 patients will be accrued for this study within 25 years
OUTLINE This is a randomized study Patients are stratified by node status positive vs negative menopause status pre- vs post estrogen receptor ER statusprogesterone receptor PR status ERPR unknown vs ERPR vs ERPR- vs ER-PR vs ER-PR- Patients in arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment courses Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for 4 treatment courses All patients who are estrogen receptor or progesterone receptor positive receive oral tamoxifen daily for 5 years following chemotherapy Some patients may also receive radiotherapy following chemotherapy Patients are followed every 3 months if patient is less than 2 years from study entry every 6 months if patient is 2-5 years from study entry and every 12 months if patient is greater than 5 years from study entry
PROJECTED ACCRUAL Approximately 2778 patients will be accrued for this study within 25 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-E2197 | None | None | None |
| E2197 | None | None | None |
| CLB-49802 | None | None | None |
| NCCTG-E2197 | None | None | None |