A phase I study of a PD-L1 antibody (Durvalumab) in combination with trastuzumab in HER-2 positive metastatic breast cancer (MBC) progressing on prior anti HER-2 therapies (CCTG IND.229)[NCT02649686].

摘要: 1029Background: Immune checkpoint inhibitors are active in a broad range of advanced cancers. Antibody dependent cell mediated cytotoxicity is mechanism action trastuzumab. The combination the two may enhance activity and/or overcome acquired resistance. We performed phase I study durvalumab and trastuzumab HER-2 positive MBC previously treated with chemotherapy anti antibodies to assess safety, efficacy correlative end-points. Methods: Patients MBC, PS 0-2, taxanes were enrolled on standard 3+3 dose escalation schedule. Dose level 1 was doses (1125 mg i.v. day 1) (8 mg/kg loading then 6 q3 weekly cycle. An expansion cohort at recommended II (RP2D) baseline post cycle tumor biopsies. primary endpoint establish RP2D. Results: 15 patients accrued across 3 Canadian centres from April – D...