SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

Inclusion criteria

• ✓. Males or females age 18 to 75 years old (inclusive) at the time of signing the informed consent form;
• ✓. Histologically and/or cytologically confirmed TNBC based on pathology reports on recent biopsy specimens or other pathological samples (central laboratory confirmation is not required), including:
• ✓. Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH).
• ✓. Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC;
• ✓. Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two lines of standard of care regimens, including:
• ✓. Any treatment received by the patients regardless of triple-negative state can be included as one of the standard of care regimens;
• ✓. For patients whose treatment regimens have been changed due to intolerability to toxicity, the intolerable regimens can be included as one of the prior standard of care regimens;
• ✓. For neoadjuvant and/or adjuvant chemotherapy, if relapse or disease progression to unresectable locally advanced or metastatic disease occurs during treatment or within 12 months after discontinuation of treatment (at least 2 cycles have been completed), it will be considered as one of the standard of care regimens. And the patients must also have received one therapy and have progressed on this therapy during the stage of unresectable locally advanced or metastatic disease;

Exclusion criteria