Spots Global Cancer Trial Database for Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

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Trial Identification

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

Official Title: A Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer

Study ID: NCT02001506

Conditions

Breast Cancer

Interventions

FEC3-D3

Study Description

Brief 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.

Detailed Description: To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.