NCT06340230

SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Conditions

• HR Positive/HER2 Low Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811 Injection + Adebrelimab Injection	Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
DRUG	SHR-A1811 Injection + Adebrelimab Injection	Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
DRUG	SHR-A1811 Injection	Drug: SHR-A1811 Injection

Timeline

• Start date: 2024-08-23
• Primary completion: 2026-02-28
• Completion: 2031-02-28
• First posted: 2024-04-01
• Last updated: 2024-12-04

Locations

1 site across 1 country: China