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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

NCT05426486 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-10-30

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Caigang Liu

    lead OTHER

Principal Investigators

  • Caigang Liu, MD · Shengjing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2025-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

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 NCT05426486 on ClinicalTrials.gov