drugset / Trial / NCT02001506

Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

NCT02001506

Phase 3 Completed 250 enrolled Asan Medical Center
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

EvaluationDrugModalityDoseRoute
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

Indications