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ACTIVE NOT RECRUITING
NCT05426486
PHASE2/PHASE3

A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Sponsor: Caigang Liu

View on ClinicalTrials.gov

Summary

This is a randomized, open label Phase II-III neoadjuvant study comparing the efficacy and safety of ARX788 combined with pyrotinib maleate versus TCBHP (trastuzumab plus pertuzumab with docetaxel and carboplatin) in patients with HER2-positive breast cancer.

Official title: A Randomized, Open Label, Multi-center Phase II-III Neoadjuvant Study Comparing the Efficacy and Safety of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) in Patients With HER2-positive Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2022-05-23

Completion Date

2028-12-30

Last Updated

2024-10-30

Healthy Volunteers

No

Interventions

DRUG

ARX788

HER2 antibody-drug conjugate

DRUG

Pyrotinib maleate

EGFR/HER2 dual inhibitor

DRUG

Trastuzumab

anti-Her2 monoclonal antibody

DRUG

Pertuzumab

anti-HER2 monoclonal antibody

DRUG

Docetaxel

Cytotoxic chemotherapy

DRUG

Carboplatin

Cytotoxic chemotherapy

Locations (1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China