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An investigator-initiated, non-randomised, phase II study of combination CTLA-4 and PD-L1 blockade in advanced HER2-positive breast cancers who have progressed on prior trastuzumab-based therapy
Australian New Zealand Breast Cancer Trials Group (ANZBCTG)
This trial involves two phases of treatment; an induction phase (weeks 1-16) and a treatment phase (weeks 17-52). During the induction phase, patients will receive 4 doses of durvalumab (1 dose every 4 weeks); 4 doses of tremelimumab (1 dose every 4 weeks); and 16 doses of trastuzumab (1 dose every week), all administered intravenously. In this phase, Oestrogen-receptor-positive patients will also start or continue with endocrine therapy. In the treatment phase, patients will only receive durvalumab and trastuzumab every 3 weeks for 12 doses (total 36 weeks).