drugset / Trial / NCT06967103

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

NCT06967103

Phase 2 Recruiting 238 enrolled Henan Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-08
Primary completion
2027-05-31
Completion
2029-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject QL1706 Monoclonal antibody
Background Epirubicin Small molecule
Background Paclitaxel Small molecule