drugset / Trial / NCT00087178
Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes.
Timeline
- Start
- 2004-05
- Primary completion
- 2014-03
- Completion
- 2016-05
Publications
- Geyer CE Jr, Bandos H, Rastogi P, Jacobs SA, Robidoux A, Fehrenbacher L, Ward PJ, Polikoff J, Brufsky AM, Provencher L, Paterson AHG, Hamm JT, Carolla RL, Baez-Diaz L, Julian TB, Swain SM, Mamounas EP, Wolmark N. Definitive results of a phase III adjuvant trial comparing six cycles of FEC-100 to four cycles of AC in women with operable node-negative breast cancer: the NSABP B-36 trial (NRG Oncology). Breast Cancer Res Treat. 2022 Jun;193(3):555-564. doi: 10.1007/s10549-021-06417-y. Epub 2022 Mar 1.
- Ganz PA, Bandos H, Geyer CE Jr, Robidoux A, Paterson AHG, Polikoff J, Baez-Diaz L, Brufsky AM, Fehrenbacher L, Parsons AW, Ward PJ, Provencher L, Hamm JT, Stella PJ, Carolla RL, Margolese RG, Shibata HR, Perez EA, Wolmark N. Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer. Breast Cancer Res Treat. 2022 Feb;192(1):153-161. doi: 10.1007/s10549-021-06475-2. Epub 2022 Feb 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |