drugset / Trial / NCT00014222
Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
Phase 3
Completed
2104 enrolled
NCIC Clinical Trials Group
Cancer and Leukemia Group B · collabNorth Central Cancer Treatment Group · collabSWOG Cancer Research Network · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2000-12-04
- Primary completion
- 2014-02-10
- Completion
- 2014-03-17
Publications
- Results Burnell MJ, O'Connor EM, Chapman JW, et al.: Triple-negative receptor status and prognosis in the NCIC CTG MA.21 adjuvant breast cancer trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-550, 2008.
- Results Burnell MJ, Levine MN, Chapman JA, et al.: A phase III adjuvant trial of sequenced EC + filgrastim + epoetin-alpha followed by paclitaxel compared to sequenced AC followed by paclitaxel compared to CEF in women with node-positive or high-risk node-negative breast cancer (NCIC CTG MA.21). [Abstract] J Clin Oncol 25 (Suppl 18): A-550, 2007.
- Results Burnell M, Levine M, Chapman JA, et al.: A randomized trial of CEF versus dose dense EC followed by paclitaxel versus AC followed by paclitaxel in women with node positive or high risk node negative breast cancer, NCIC CTG MA.21: results of an interim analysis. [Abstract] 29th Annual San Antonio Breast Cancer Symposium, December 14-17, 2006, San Antonio, Texas. A-53, 2006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 75 mg/m2 | Oral |
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Oral |
| Comparator | Cyclophosphamide | Other / unclassified | 830 mg/m2 | Oral |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Comparator | epoetin alfa | Protein / enzyme biologic | 40000 iu | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 5 mg/kg | Subcutaneous |
| Comparator | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |