A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined
This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer. After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The stand
| Condition(s) | TNBC, Adjuvant Therapy, Lymph Node Positive |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer. After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intoler |
| Who can participate | Inclusion Criteria: 1. The participant voluntarily joins this study and signs the informed consent form. 2. Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC 2+/ISH-) based on the most recent biopsy or other pathological specimen, according to the latest ASCO/CAP guidelines. Patients with low ER or PR expression (1%-10%) may also be included in this study. 3. Patients with high-risk TNBC (defined as lymph node-positive). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Agree to provide intraoperatively obtained tumor histopathological specimens (FFPE, at least 5 sections) for biomarker testing. 6. Expected survival ≥3 months. 7. Function of vital organs meets the f |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2026-06-05 |
| NCT ID | NCT07622836 |
| Official listing | https://clinicaltrials.gov/study/NCT07622836 |