Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

• Histological confirmation of breast cancer with locally recurrent or unresectable disease who have failed prior therapy
• If HER2 positive, must have been previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimens
• If ER or PR positive, must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy
• If Triple negative must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens which can include neoadjuvant or adjuvant therapy
• If known germline mutations must have been treated with all tumor directed indicated treatment (e.g. PARPi) if tolerated
• In HER2-low patients in addition to the appropriate therapies based on ER/PR status and germline or genomic actionable targets, must also have received HER2 low directed therapy
• No active brain mets, but treated or stable brain mets can enroll
• ECOG PS 0-2
• Known active hepatitis or AIDS

• Primary
  • OS
• Secondary
  • PFS
  • CBR
  • ORR
  • QOL
  • CNS event free survival