An investigator-initiated, non-randomised, phase II study of combination CTLA-4 and PD-L1 blockade in combination with HER2 blockade in advanced HER2-positive breast cancers that have progressed on prior trastuzumab-based therapy (BCT 1703 DIAmOND)

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 72 patients with advanced HER2-positive breast cancer that have progressed on prior trastuzumab-based therapy. Three cohorts: Cohort 1: ER-positive patients; Cohort 2: ER-negative patients; both cohorts treated with 16 week induction phase with tremelimumab 75mg q4w IV, durvalumab 1500mg q4w IV and trastuzumab 2mg/kg q1w IV. Followed by Treatment phase (weeks 17-52) durvalumab 1120mg q3wIV & trastuzumab 6mg/kg q3w IV. Cohort 3: all patients treated with tremelimumab priming dose single 300 mg dose, with durvalumab 1120mg administered with tremelimumab on Day 1 and continued q3w for up to 18 doses. Primary objectives: Cohorts 1 & 2 - Percentage of participants alive and progression free, determined by RECIST 1.1; Cohort 3 - Objective response rate by RECIST 1.1. Cancer Australia demographic data has been collected including: Year of birth, Postcode of usual residence, Indigenous Status, CALD status (Country of Birth, Main language other than English used as the principle means of communication).