Phase II Study of Postoperative Chemotherapy and QL1706 in Women with High-Risk Triple-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining postoperative chemotherapy with the drug QL1706 in patients with high-risk triple-negative breast cancer. This prospective, multicenter phase II clinical trial focuses on patients diagnosed with this aggressive breast cancer subtype, particularly those with lymph node involvement, to improve disease-free survival outcomes. Participants will receive eight cycles of chemotherapy alongside QL1706 after enrollment. The standard chemotherapy regimen used is the AC-T regimen, which includes four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane. After completing these cycles, from cycle nine onwards, participants will receive QL1706 alone as maintenance treatment. Treatment will continue until specified discontinuation criteria are met, intolerable side effects occur, or consent is withdrawn, with a maximum of 17 QL1706 dosing cycles. During the study, safety assessments will occur every three weeks, and imaging evaluations will be performed every twelve weeks to monitor disease progression. After treatment ends, participants will undergo safety and survival follow-up, and if treatment is stopped for reasons other than disease progression or death, tumor progression will also be monitored. The primary outcome measured is the three-year disease-free survival rate, with additional tracking of distant disease-free survival within the same period.

A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.