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ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC
Sponsor: Sun Yat-sen University
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.
Official title: A Multi-center Randomized Phase II Study of Doxorubicin Liposome Versus Epirubicin Plus Cyclophosphamide Combined With Trastuzumab and Pertuzumab(HP), Followed by Taxon Plus HP as Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2019-01-10
Completion Date
2026-09-30
Last Updated
2023-10-16
Healthy Volunteers
No
Conditions
Interventions
Doxorubicin liposome
PLD
Cyclophosphamide
CTX
Trastuzumab
H
Docetaxel
DOC
Epirubicin
EPI
Pertuzumab
P
Paclitaxel
paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week
Paclitaxel-albumin
albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China