Breast cancer
Conditions
Interventions
Triat group:1. Neoadjuvant chemotherapy phase:
(1) Hormone receptor-positive patients: TA regimen (nab-paclitaxel 125 mg/m^2 + epirubicin 75-100 mg/m^2, q3w, day 1, for 3 cycles)
(2) Triple-negative breast cancer patients: TP regimen (nab-paclitaxel 125 mg/m^2 + carboplatin AUC=5-6, q3w × 3).
After 3 cycles of chemotherapy, treatment response is evaluated (CR/PR/SD/PD).
2
(2) SD/PD patients receive stereotactic radiotherapy (SRT, CyberKnife or X-Knife, 3×8 Gy, targeting the primary tumor)
(3) QL1706 (5 mg/kg, IV, q3w, total 3 doses) is initiated 2 weeks after the start of radiotherapy
(4) Surgery is performed within 8 weeks after the last dose.
3. Adjuvant therapy post-surgery:
Based on the 2025 CSCO BC Guidelines, the treating physician decides whether to continue QL1706 or o
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed stage II-III breast cancer; 2. Invasive HER2-negative breast cancer confirmed by histopathology and immunohistochemistry; 3. Histological grade G2 or G3; 4. Ki67 >= 15% (high risk of recurrence); 5. Age 18 to 70 years (inclusive); 6. Tumor size evaluable; 7. KPS performance status score >= 70; 8. Adequate bone marrow reserve: total white blood cell count >= 4.0×10^9/L, neutrophils >= 2.0×10^9/L; platelets >= 100×10^9/L; hemoglobin >= 90 g/L; 9. ECOG 0-1; 10. Serum creatinine 44–133 µmol/L; 11. AST, ALT, and alkaline phosphatase = 50%; 13. Expected survival >= 12 weeks; 14. Willing to provide tumor tissue and blood samples for subsequent mechanistic studies; if not, inclusion requires investigator approval; 15. Pre-treatment pregnancy test must be negative in women of childbearing potential; patients and their partners must agree to use effective contraception during treatment and for one year thereafter; 16. Voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. First diagnosis of stage IV breast cancer; 2. Severe systemic infection; 3. Allergy to known research drugs or any of their excipients; 4. Any investigational drug has been used within 30 days prior to the first administration, and radiotherapy or other chemotherapy drugs have been received; 5. Any situation where the researcher believes that participating in the trial is not in the best interests of the subjects (such as endangering their health) or would impede the evaluation of the trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related adverse event;Pathological compelte response;Event free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLiu Yunjiang
The Fourth Hospital of Hebei Medical University
Outcome results
None listed