Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070564
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2003-10-03
Brief Title:
S0221 Adjuvant Doxorubicin Cyclophosphamide and Paclitaxel in Treating Patients With Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Trial of Continuous Schedule AC G vs Q 2 Week Schedule AC Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 such as doxorubicin cyclophosphamide and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them after surgery may kill any remaining tumor cells It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer
PURPOSE This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I stage II or stage III breast cancer
PURPOSE This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 2 different schedules of adjuvant doxorubicin cyclophosphamide and paclitaxel
Compare the overall survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Correlate outcome with putative prognostic markers in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms arms V and VI arms I-IV closed 111010
Arm I closed 111010 Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously SC on day 2 or filgrastim G-CSF SC on days 3-10 Treatment repeats every 14 days for 6 courses
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 6 courses
Arm II closed 111010 Patients receive doxorubicin IV on day 1 oral cyclophosphamide on days 1-7 and G-CSF SC on days 2-7 Treatment repeats every 7 days for 15 courses
Beginning 2 weeks after completion of cyclophosphamide patients receive paclitaxel and pegfilgrastim as in arm I
Arm III closed 111010 Patients receive doxorubicin cyclophosphamide and pegfilgrastim or G-CSF as in arm I
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 1 hour on day 1 Treatment repeats every 7 days for 12 courses
Arm IV closed 111010 Patients receive doxorubicin cyclophosphamide and G-CSF as in arm II
Beginning 2 weeks after completion of cyclophosphamide patients receive paclitaxel as in arm III
Arm V Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 4 courses Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 6 courses
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 6 courses
Arm VI Patients receive doxorubicin cyclophosphamide and pegfilgrastim as in arm V
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 1 hour on day 1 Treatment repeats every 7 days for 12 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
In all arms patients with HER2neu-positive tumors also receive trastuzumab Herceptin weekly or every 3 weeks beginning concurrently with paclitaxel OR 3 months after the last dose of paclitaxel and continuing for up to 52 weeks
In all arms patients with estrogen-receptor or progesterone-receptor positive tumors receive hormonal therapy beginning within 28 days of the completion of adjuvant chemotherapy or radiotherapy if given
After finishing study treatment patients are followed up every 6 months for 5 years and then once a year for up to 15 years
PROJECTED ACCRUAL A total of 3250 patients will be accrued for this study
Compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 2 different schedules of adjuvant doxorubicin cyclophosphamide and paclitaxel
Compare the overall survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Correlate outcome with putative prognostic markers in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms arms V and VI arms I-IV closed 111010
Arm I closed 111010 Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously SC on day 2 or filgrastim G-CSF SC on days 3-10 Treatment repeats every 14 days for 6 courses
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 6 courses
Arm II closed 111010 Patients receive doxorubicin IV on day 1 oral cyclophosphamide on days 1-7 and G-CSF SC on days 2-7 Treatment repeats every 7 days for 15 courses
Beginning 2 weeks after completion of cyclophosphamide patients receive paclitaxel and pegfilgrastim as in arm I
Arm III closed 111010 Patients receive doxorubicin cyclophosphamide and pegfilgrastim or G-CSF as in arm I
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 1 hour on day 1 Treatment repeats every 7 days for 12 courses
Arm IV closed 111010 Patients receive doxorubicin cyclophosphamide and G-CSF as in arm II
Beginning 2 weeks after completion of cyclophosphamide patients receive paclitaxel as in arm III
Arm V Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 4 courses Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 6 courses
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2 Treatment repeats every 14 days for 6 courses
Arm VI Patients receive doxorubicin cyclophosphamide and pegfilgrastim as in arm V
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 1 hour on day 1 Treatment repeats every 7 days for 12 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
In all arms patients with HER2neu-positive tumors also receive trastuzumab Herceptin weekly or every 3 weeks beginning concurrently with paclitaxel OR 3 months after the last dose of paclitaxel and continuing for up to 52 weeks
In all arms patients with estrogen-receptor or progesterone-receptor positive tumors receive hormonal therapy beginning within 28 days of the completion of adjuvant chemotherapy or radiotherapy if given
After finishing study treatment patients are followed up every 6 months for 5 years and then once a year for up to 15 years
PROJECTED ACCRUAL A total of 3250 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0221 | OTHER | None | None |