Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003088
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin Paclitaxel and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage IIIIIA Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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 drugs at different times or combining more than one drug may kill more tumor cells It is not yet known which chemotherapy regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin cyclophosphamide or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin cyclophosphamide or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES I Compare the sequential chemotherapy with doxorubicin paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer II Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival III Compare the toxicity in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized into one of four arms sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection Adjuvant chemotherapy is started within 84 days following the last surgical procedure Arm I Patients receive sequential chemotherapy every 3 weeks Doxorubicin IV is administered once every 3 weeks for 4 doses Paclitaxel IV is then administered over 3 hours once every 3 weeks for 4 doses Cyclophosphamide IV is administered once every 3 weeks for 4 doses following paclitaxel Arm II Patients receive sequential chemotherapy every 2 weeks Doxorubicin IV is administered once every 2 weeks for 4 doses Paclitaxel IV is then administered over 3 hours once every 2 weeks for 4 doses Cyclophosphamide IV is administered once every 2 weeks for 4 doses following paclitaxel Filgrastim G-CSF is administered by subcutaneous injection on days 3-10 after each dose of doxorubicin paclitaxel and cyclophosphamide Arm III Patients receive combination chemotherapy every 3 weeks Combination doxorubicin IV and cyclophosphamide IV is administered once every 3 weeks for 4 doses Paclitaxel IV is administered over 3 hours once every 3 weeks for 4 doses following combination chemotherapy Arm IV Patients receive combination chemotherapy every 2 weeks Combination doxorubicin IV and cyclophosphamide IV is administered once every 2 weeks for 4 doses Paclitaxel IV is administered over 3 hours once every 2 weeks for 4 doses following combination chemotherapy G-CSF is administered by subcutaneous injection on days 3-10 after each dose of doxorubicincyclophophamide and after each dose of paclitaxel After completion of all chemotherapy patients receive tamoxifen orally for 5 years Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy Patients are followed every 6 months for 5 years then annually until death
PROJECTED ACCRUAL A total of 2000 patients will be accrued for this study within 22 months
OUTLINE This is a randomized study Patients are randomized into one of four arms sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection Adjuvant chemotherapy is started within 84 days following the last surgical procedure Arm I Patients receive sequential chemotherapy every 3 weeks Doxorubicin IV is administered once every 3 weeks for 4 doses Paclitaxel IV is then administered over 3 hours once every 3 weeks for 4 doses Cyclophosphamide IV is administered once every 3 weeks for 4 doses following paclitaxel Arm II Patients receive sequential chemotherapy every 2 weeks Doxorubicin IV is administered once every 2 weeks for 4 doses Paclitaxel IV is then administered over 3 hours once every 2 weeks for 4 doses Cyclophosphamide IV is administered once every 2 weeks for 4 doses following paclitaxel Filgrastim G-CSF is administered by subcutaneous injection on days 3-10 after each dose of doxorubicin paclitaxel and cyclophosphamide Arm III Patients receive combination chemotherapy every 3 weeks Combination doxorubicin IV and cyclophosphamide IV is administered once every 3 weeks for 4 doses Paclitaxel IV is administered over 3 hours once every 3 weeks for 4 doses following combination chemotherapy Arm IV Patients receive combination chemotherapy every 2 weeks Combination doxorubicin IV and cyclophosphamide IV is administered once every 2 weeks for 4 doses Paclitaxel IV is administered over 3 hours once every 2 weeks for 4 doses following combination chemotherapy G-CSF is administered by subcutaneous injection on days 3-10 after each dose of doxorubicincyclophophamide and after each dose of paclitaxel After completion of all chemotherapy patients receive tamoxifen orally for 5 years Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy Patients are followed every 6 months for 5 years then annually until death
PROJECTED ACCRUAL A total of 2000 patients will be accrued for this study within 22 months
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-9741 | None | None | None |
| CDR0000065788 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |