Study of QL1706 With Albumin-Bound Paclitaxel With or Without Bevacizumab as First-Line Treatment for Recurrent or Metastatic Triple-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the drug QL1706 combined with albumin-bound paclitaxel, with or without bevacizumab, as a first-line treatment for women with recurrent or metastatic triple-negative breast cancer rmTNBC. This non-randomized, phase II study is designed to understand how these treatments work together in this specific breast cancer type, which lacks certain hormone receptors and HER2 expression. Participants will receive QL1706, a bispecific antibody targeting PD-1 and CTLA-4, along with albumin-bound paclitaxel nab-paclitaxel. Some will also receive bevacizumab. The study involves two treatment groups one receiving QL1706 plus nab-paclitaxel, and the other receiving QL1706 plus nab-paclitaxel with bevacizumab. Treatments are given as part of an ongoing regimen, with assessments every six weeks up to one year. During the study, participants will be closely monitored with evaluations of tumor response using RECIST 1.1 criteria at baseline and every six weeks for up to one year. Researchers will also assess safety by tracking adverse events from the start of treatment until three months after the last dose. Additional follow-up will measure progression-free survival up to two years and overall survival up to three years. Participants will undergo laboratory tests, tumor tissue biomarker analysis, and clinical assessments, with study participation lasting up to three years including follow-up.

QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC