NCT03140553

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

TCH (Docetaxel/Carboplatin/Trastuzumab) Versus EC -TH(Epirubicin/Cyclophosphamide Followed by Docetaxe/Trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)	TCH (docetaxel/carboplatin/trastuzumab) versus EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2017-05-04
• Last updated: 2020-07-28

Locations

1 site across 1 country: China