NCT07294534

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

An Open-Label, Randomized, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87 (HER2 ADC) in Combination With HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) or Pertuzumab vs. TCbHP in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 817 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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+

Timeline

• Start date: 2026-01-27
• Primary completion: 2028-09-30
• Completion: 2030-02-01
• First posted: 2025-12-19
• Last updated: 2025-12-19