Restoring sensitivity to immunotherapy in advanced triple negative breast cancer exploiting ceralasertib priming followed by combined durvalumab/nab-paclitaxel: the Atribrave trial

PI: Dr. Claudio Vernieri   

This is a Phase II, single-arm, open-label, non-profit study in patients with unresectable locally advanced or metastatic TNBC whose tumor has relapsed after prior curative treatment for early disease, which must have included ICI and chemotherapy as part of locoregional radical therapy (adjuvant, neoadjuvant, or both). ATRiBRAVE proposes the administration of an ATR inhibitor (ATRi), called ceralasertib, in combination with chemotherapy and immunotherapy as a novel approach to enhance and/or restore sensitivity to immunotherapy after it has failed in the treatment of early disease in TNBC (triple-negative) tumors. The study aims to evaluate the efficacy and therefore the ability to improve progression-free survival and safety of the treatments under study.