NCT01314833

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,570 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel Cyclophosphamide	Docetaxel 75 mg/m² D1 Cyclophosphamide 600 mg/m² D1 1 cycle = 21 days TC\*6
DRUG	Cyclophosphamide Fluorouracil Epirubicin Docetaxel	1st -3rd Cycle: Fluorouracil 500 mg/m² D1 Epirubicin 100 mg/m² D1 Cyclophosphamide 500 mg/m² D1 1 cycle = 21 days 4th-6th Cycle: Docetaxel 100mg/m² D1 1 cycle = 21 days CEF\*3-T\*3
DRUG	Epirubicin Cyclophosphamide Paclitaxel	1st-4th Cycle: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1 1 cycle = 21 days 5th-8th Cycle: Paclitaxel 80mg/m² D1, 8, 15 1 cycle = 21 days EC\*4-P\*4

Timeline

• Start date: 2010-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-15
• First posted: 2011-03-15
• Last updated: 2020-05-19

Locations

1 site across 1 country: China