NCT04514419

Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel

A Phase III Study to Compare HS627 vs. Pertuzumab on the Efficacy, Safety and Immunogenicity in Combination With Trastuzumab and Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2 Positive Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).

Detailed description

A multicenter, randomized, double-blind, positive drug parallel control design was used. The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks). All eligible subjects were randomly divided into experimental group (hs627 treatment group) and control group (pertuzumab) treatment group. After 4 treatment cycles, the subjects arranged surgical treatment, and then conducted the last visit.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	HS627	Prior to surgery: trastuzumab, HS627, and docetaxel for 4 cycles (1 cycle = 21 days).
DRUG	Pertuzumab	Prior to surgery: trastuzumab, Pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days).

Timeline

• Start date: 2020-06-28
• Primary completion: 2024-09-11
• Completion: 2025-12-01
• First posted: 2020-08-17
• Last updated: 2025-11-21

Locations

1 site across 1 country: China