NCT06967103

QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer

QL1706 Combined With PE Compared With PE for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are: Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.

Conditions

• Breast Cancer
• HR+/HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	QL1706	bispecific antibody targeting PD-1 and CLTA-4
DRUG	Nab-PE	Nab-paclitaxel+Epirubicin

Timeline

• Start date: 2025-09-08
• Primary completion: 2027-05-31
• Completion: 2029-05-30
• First posted: 2025-05-13
• Last updated: 2026-01-08

Locations

1 site across 1 country: China