A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).
• Voluntarily sign a written informed consent form.
• Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of ≥ 3 months.
• Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
• Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
• Suitable for monotherapy with taxane-based agents.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Adequate organ function.