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A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer

NCT07294534 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 817

Last updated 2025-12-19

No results posted yet for this study

Summary

The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.

Conditions

  • HER2 + Breast Cancer

Interventions

DRUG

HLX87+HX22

HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2

DRUG

HLX87 + Pertuzumab

HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan.

DRUG

TCbHP

Docetaxel +Carboplatin+Trastuzumab+Pertuzumab+

Sponsors & Collaborators

Principal Investigators

  • Zhiming Shao, Dr · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2028-09-30
Completion
2030-02-01

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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 NCT07294534 on ClinicalTrials.gov