Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014222
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2001-04-10
Brief Title:
Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Adjuvant Trial Of Sequenced EC Filgrastim Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery For Node Positive Or High Risk Node Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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
1 To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease
2 It is not yet known which treatment regimen is most effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I stage II or stage III breast cancer
1 To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease
2 It is not yet known which treatment regimen is most effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the disease-free survival of premenopausal or early postmenopausal women with previously resected node positive or high-risk node negative stage I-IIIB breast cancer treated with cyclophosphamide epirubicin and fluorouracil vs cyclophosphamide epirubicin filgrastim G-CSF and epoetin alfa followed by paclitaxel vs cyclophosphamide and doxorubicin followed by paclitaxel
Secondary
Compare the overall survival of patients treated with these regimens
Compare the rate of toxic effects of these regimens in this patient population
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive nodes 0 vs 1-3 vs 4-10 vs more than 10 type of prior surgery total vs partial mastectomy and estrogen receptor status positive vs negative Patients are randomized to one of three treatment arms
Arm I Patients receive epirubicin IV and fluorouracil IV on days 1 and 8 and oral cyclophosphamide on days 1-14 Treatment repeats every 28 days for 6 courses
Arm II Patients receive epirubicin IV and cyclophosphamide IV on day 1 and filgrastim G-CSF subcutaneously SC on days 2-13 Patients with a hemoglobin 130 gdL also receive epoetin alfa SC once weekly beginning within 1 week after the start of therapy and continuing as needed Treatment repeats every 14 days for 6 courses Beginning 21 days after completion of epirubicin and cyclophosphamide patients receive paclitaxel IV over 3 hours on day 1 and G-CSF and epoetin alfa as above Treatment repeats every 21 days for 4 courses
Arm III Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 Treatment repeats every 21 days for 4 courses Beginning 21 days after completion of doxorubicin and cyclophosphamide patients receive paclitaxel as in arm II Treatment in all arms continues in the absence of disease progression or unacceptable toxicity
All receptor positive patients receive oral tamoxifen or anastrozole if tamoxifen is contraindicated for 5 years after completion of chemotherapy
Quality of life is assessed at baseline day 1 of cycles 2 3 4 and 6 arm I days 1 of cycles 3 and and day 1 of cycles 1 and 4 of paclitaxel arm II day 1 of cycles 2 and 3 day 1 of cycles 1 and 4 of paclitaxel arm III 9 months 12 months and then annually thereafter until 5 years
Patients are followed at 9 months 12 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 2100 patients 700 per treatment arm will be accrued for this study within 4 years
Primary
Compare the disease-free survival of premenopausal or early postmenopausal women with previously resected node positive or high-risk node negative stage I-IIIB breast cancer treated with cyclophosphamide epirubicin and fluorouracil vs cyclophosphamide epirubicin filgrastim G-CSF and epoetin alfa followed by paclitaxel vs cyclophosphamide and doxorubicin followed by paclitaxel
Secondary
Compare the overall survival of patients treated with these regimens
Compare the rate of toxic effects of these regimens in this patient population
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive nodes 0 vs 1-3 vs 4-10 vs more than 10 type of prior surgery total vs partial mastectomy and estrogen receptor status positive vs negative Patients are randomized to one of three treatment arms
Arm I Patients receive epirubicin IV and fluorouracil IV on days 1 and 8 and oral cyclophosphamide on days 1-14 Treatment repeats every 28 days for 6 courses
Arm II Patients receive epirubicin IV and cyclophosphamide IV on day 1 and filgrastim G-CSF subcutaneously SC on days 2-13 Patients with a hemoglobin 130 gdL also receive epoetin alfa SC once weekly beginning within 1 week after the start of therapy and continuing as needed Treatment repeats every 14 days for 6 courses Beginning 21 days after completion of epirubicin and cyclophosphamide patients receive paclitaxel IV over 3 hours on day 1 and G-CSF and epoetin alfa as above Treatment repeats every 21 days for 4 courses
Arm III Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 Treatment repeats every 21 days for 4 courses Beginning 21 days after completion of doxorubicin and cyclophosphamide patients receive paclitaxel as in arm II Treatment in all arms continues in the absence of disease progression or unacceptable toxicity
All receptor positive patients receive oral tamoxifen or anastrozole if tamoxifen is contraindicated for 5 years after completion of chemotherapy
Quality of life is assessed at baseline day 1 of cycles 2 3 4 and 6 arm I days 1 of cycles 3 and and day 1 of cycles 1 and 4 of paclitaxel arm II day 1 of cycles 2 and 3 day 1 of cycles 1 and 4 of paclitaxel arm III 9 months 12 months and then annually thereafter until 5 years
Patients are followed at 9 months 12 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 2100 patients 700 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CALGB-CAN-NCIC-MA21 | OTHER | Participating group | None |
| CAN-NCIC-MA21 | REGISTRY | None | None |
| AMGEN-CAN-NCIC-MA21 | OTHER | None | None |
| NCCTG-CAN-NCIC-MA21 | OTHER | None | None |
| BMS-CAN-NCIC-MA21 | OTHER | None | None |
| JANSSEN-ORTHO-CAN-NCIC-MA21 | OTHER | None | None |
| PFIZER-CAN-NCIC-MA21 | OTHER | None | None |
| SWOG-CAN-NCIC-MA21 | OTHER | None | None |
| CDR0000068520 | OTHER | None | None |