QL1706 Combined With PE Compared With PE for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
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.
• Subjects meeting all of the following criteria are eligible for inclusion in this study:
• Voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.
• Female, aged ≥18 years .
• Evaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.
• cT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• Histologically and/or cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor \[ER\] or progesterone receptor \[PR\] nuclear staining \>1%) with Ki67 ≥20%.
• HER2-negative breast cancer, defined as:
• Negative in situ hybridization (ISH) results; or
• Immunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative.
• Willing to provide fresh or archived tumor tissue samples.
• At least one measurable lesion per RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate organ function, defined as:
• Hematology:
• Hemoglobin ≥90 g/L
• Absolute neutrophil count ≥1.5 × 10⁹/L
• Platelet count ≥100 × 10⁹/L.
• Biochemistry:
• ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present);
• Total bilirubin ≤1.5 × ULN;
• Serum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min.
• Coagulation:
• Activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• International normalized ratio (INR) ≤1.5 × ULN.
• Cardiac function:
• Left ventricular ejection fraction (LVEF) ≥50% by echocardiography.
• Premenopausal or perimenopausal subjects must agree to use reliable and effective contraception or practice abstinence from the time of informed consent until at least 90 days after the last dose of study treatment.