QL1706 Plus Nab-paclitaxel +/- Bevacizumab As 1L Treatment in Recurrent or Metastatic Triple-Negative Breast Cancer: a Non-randomized, Multicenter Phase II Study
This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC
• Voluntarily join this study and sign the informed consent form;
• Female patients aged ≥18 years and ≤70 years old who had been dignosed with breast cancer;
• According to the definition of the latest ASCO/CAP guidelines, histologically confirmed estrogen receptor negative (ER-) and progesterone receptor negative (PR-), human epidermal growth factor receptor 2 negative
• For patients with locally advanced, recurrent or metastatic breast cancer who have not used any systematic treatment (it is allowed to accept adjuvant/neoadjuvant treatment, and the time from the last administration to recurrence and metastasis should be ≥ 6 months);
• According to RECIST 1.1, there is at least one measurable lesion;
• ECOG score: 0\
⁃ 1;
• Tumor tissue specimens that can be used for biomarker detection;
• Adequate organ function (no blood components or cell growth factor drugs are allowed within 14 days before the first medication): (1) Absolute neutrophil count ≥1.5×109/L; (2) Platelets ≥100×109/L; (3) Hemoglobin ≥90 g/L; (4) Serum albumin ≥30 g/L; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN，if liver metastasis is present, ≤3ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).