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Brief 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 Operable Breast Cancer (MASTER)
Official Title: Adjuvant Six Cycles of Docetaxel and Cyclophosphamide or Three Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by Three Cycles of Docetaxel Versus Four Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer
Study ID: NCT04127019
Brief Summary: We aimed to evaluate the noninferiority of a short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or a 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 operable breast cancer.
Detailed Description: It was initiated as an adjuvant chemotherapy trial in 2010 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 \[EC-P\]). Patients were randomly assigned (1:1:1) to each arm after completing surgical excision of primary tumor. Trastuzumab was administered in combination with chemotherapy to patients with HER2-positive breast cancer and sustained monotherapy as per the current guidelines.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Name: Zhi-Ming Shao
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR