RecruitingPhase 2NCT06967103

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

Sponsor

Henan Cancer Hospital

Enrollment

238 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer HR+/HER2- Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing QL1706 — a dual immunotherapy drug — alongside chemotherapy before surgery (neoadjuvant treatment) for women with hormone receptor-positive, HER2-negative breast cancer, to see if it can improve surgical outcomes. **You may be eligible if...** - You are a woman aged 18 or older - You have histologically confirmed HR+/HER2-negative breast cancer - Your tumor is a specific size and stage (cT2–T4d N0–N3, or cT1c with confirmed lymph node spread) - You have not received any prior systemic anti-tumor treatment for this breast cancer - You are in good enough health to tolerate surgery **You may NOT be eligible if...** - You have distant metastases (cancer has spread to other organs) - You have prior breast cancer treatment history - You are pregnant or breastfeeding - You have significant autoimmune or immune-related conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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