Exploratory Study of QL1706 With Short-Cycle Anthracyclines or Taxanes for Early-Stage Triple-Negative Breast Cancer

What this Trial Is About

Triple-negative breast cancer TNBC is a fast-growing and often recurring form of breast cancer that lacks specific receptors for targeted treatment, making chemotherapy the standard approach. This study explores the use of a new immune therapy drug called QL1706, which combines two antibodies to help the immune system fight cancer. Researchers aim to understand if combining QL1706 with different chemotherapy drugs can improve treatment for early-stage TNBC patients and whether chemotherapy doses can be safely reduced. The trial randomizes 30 patients with early-stage TNBC into two groups. One group receives QL1706 plus nab-paclitaxel and carboplatin, while the other receives QL1706 combined with pirarubicin and cyclophosphamide. Each patient undergoes four treatment cycles. If a complete response is achieved, no further chemotherapy is given. If not, additional cycles of both chemotherapy combinations with QL1706 are administered. This approach tests the effectiveness of short-cycle anthracycline or taxane chemotherapy combined with QL1706. Participants will be closely monitored from the first dose until surgery, approximately 12 to 16 weeks later. Researchers will track tumor response rates, treatment safety, and patient health through exams, lab tests, and imaging. The study also requires patients to meet specific health and performance criteria and includes follow-up to assess treatment outcomes. The goal is to find a more effective and potentially less intense treatment option for TNBC patients.

A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC