QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
NCT06967103 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 238
Last updated 2026-01-08
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
- DRUG
-
QL1706
bispecific antibody targeting PD-1 and CLTA-4
- DRUG
-
Nab-PE
Nab-paclitaxel+Epirubicin
Sponsors & Collaborators
-
Henan Cancer Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-08
- Primary Completion
- 2027-05-31
- Completion
- 2029-05-30
Countries
- China
Study Locations
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