NCT02455141

Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 786 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.

Detailed description

This study plans to enroll triple-negative breast cancer patients who have complete tumor removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the basis of weekly paclitaxel adjuvant chemotherapy.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	Epirubicin plus Cyclophosphamide	Epirubicin 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4
DRUG	Taxanes	Paclitaxel: 80mg/m2, d1, qw\*12 or Docetaxel: 80-100mg/m2,d1,q3w\*4
DRUG	Taxanes plus Carboplatin	Paclitaxel: 80mg/m2, d1,d8,d15, q4w\*4 Carboplatin AUC=2, d1,d8,d15, q4w\*4 or Docetaxel: 75mg/m2,d1,q3w\*4 plus Carboplatin AUC=5-6, d1, q3w\*4

Timeline

• Start date: 2016-03-01
• Primary completion: 2027-03-01
• Completion: 2030-03-01
• First posted: 2015-05-27
• Last updated: 2025-07-11

Locations

27 sites across 1 country: China