drugset / Trial / NCT02001506
Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.
Timeline
- Start
- 2012-11
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 500 unknown | — |
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 100 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 500 mg/m2 | — |