Minus Anthracycline or Short-Term Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel Regimen for Adjuvant Breast Cancer Therapy

Primary Breast Cancer Clinical Trial

Official title: Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in HER2-negative Operable Breast Cancer

Status Completed

Clinical Trial Summary

We aimed to evaluate the noninferiority of short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or short-term anthracycline-based chemotherapy (CEF-T, three cycles of cyclophosphamide/epirubicin/fluorouracil followed by three cycles of docetaxel) to a standard anthracycline/taxane-containing chemotherapy (EC-P, epirubicin, and cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in HER2-negative operable breast cancer.

Clinical Trial Description

It was initiated as an adjuvant chemotherapy trial to test noninferiority of an anthracycline-free short-term regimen (T75C600 x 6 [TC] once every 3 weeks) or a short-term regimen (C500E100F500 x 3 once every 3 weeks followed by T100 x 3 every 3 weeks [CEF-T]) compared with a standard long-term anthracycline-containing regimen (E90C600 x 4 once every 3 weeks followed by P80 x 12 once every week [EC-P]) in HER2-negative breast cancer. Patients were randomly assigned (1:1:1) to each arm after completing the surgical excision of the primary tumor. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Primary Breast Cancer

• NCT number: NCT01314833
• Study type: Interventional
• Source: Fudan University
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2010
• Completion date: June 15, 2017