AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

Exclusion Criteria

• •1. Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
• •2. History of other malignancies within the past 5 years.
• •3. Active autoimmune disease requiring systemic treatment within the past 2 years.
• •4. Pregnant or breastfeeding women.
• •5. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
• •6. Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
• •7. Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.
• •8. Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.