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ACTIVE NOT RECRUITING
NCT04172259
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

Doxorubicin liposome

PLD

DRUG

Cyclophosphamide

CTX

DRUG

Trastuzumab

H

DRUG

Docetaxel

DOC

DRUG

Epirubicin

EPI

DRUG

Pertuzumab

P

DRUG

Paclitaxel

paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week

DRUG

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