drugset / Trial / NCT04172259

ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC

NCT04172259

RandomizedParallel-groupOpen-labelTreatment

Summary

Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab may improve DFS rate. In this study, the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy. We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients.

Timeline

Start
2019-01-10
Primary completion
2023-09-30
Completion
2026-09-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin liposome Unknown 35 mg/m2
Comparator Epirubicin Small molecule 90 mg/m2
Background Cyclophosphamide Other / unclassified 600 mg/m2
Background Docetaxel Small molecule 75 mg/m2
Background Paclitaxel Small molecule 80 mg/m2
Background Paclitaxel Small molecule 100 mg/m2
Background Paclitaxel Small molecule 175 mg/m2
Background Paclitaxel Small molecule 260 mg/m2
Background Pertuzumab Monoclonal antibody 420 mg
Background Trastuzumab Monoclonal antibody 6 mg/kg

Indications