NCT07196774

A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer

A Randomized, Open-label, Multicenter Phase III Study of SHR-A1811 Compared to Docetaxel+Carboplatin+Trastuzumab+Pertuzumab as a Neoadjuvant Therapy for the Initial Treatment of Early-stage or Locally Advanced HER2-positive Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 740 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.

Conditions

• Early-stage or Locally Advanced HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811 for Injection	SHR-A1811 for injection.
DRUG	Docetaxel injection	Docetaxel injection.
DRUG	Trastuzumab Injection	Trastuzumab injection.
DRUG	Carboplatin for Injection	Carboplatin for injection.
DRUG	Pertuzumab Injection	Pertuzumab injection.

Timeline

• Start date: 2025-10-23
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-09-29
• Last updated: 2026-01-30

Locations

2 sites across 1 country: China