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

NCT04172259 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-10-16

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Wen Xia, MD · SunYat-sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04172259 on ClinicalTrials.gov