drugset / Trial / NCT03140553

TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer

NCT03140553 ↗

Phase 2 Completed 140 enrolled Guangdong Provincial People's Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment in HER2-Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

Timeline

Start
2016-09-01
Primary completion
2019-11-11
Completion
2019-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2 —
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Epirubicin Small molecule 90 mg/m2 —
Subject Trastuzumab Monoclonal antibody — —