Phase 1b/2, Multicenter, Open-label, Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3-DXd monotherapy and combinations in Patients with inoperable advanced breast cancer (ABC) after progression on T-DXd- (ICARUS BREAST 2)

Quick answer

Phase 1b/2, Multicenter, Open-label, Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3-DXd monotherapy and combinations in Patients with inoperable advanced breast cancer (ABC) after progression on T-DXd- (ICARUS BREAST 2) for Patients with HER2-positive (HER2-pos) (cohort 1) or HER2-low defined as a score 1+ on immunohistochemistry [IHC] or as an IHC score 2+ and negative results on in situ hybridization (ISH) (cohort 2) ABC, and any hormone receptor (HR) status, who have progressed on trastuzumab deruxtecan (T-DXd). In addition to previous T-DXd, patients with HER2-pos tumors must have received prior treatment with trastuzumab (+/- pertuzumab) and taxanes and may have received T-DM1. Patients with HER2-low tumors must have received prior treatment with taxanes. Patients with HR-positive (HR+) and HER2-low tumor must have received prior treatment with endocrine therapy and CDK4/6 inhibitors. is a Phase 2 program (other) at Institut für biomedizinische Analytik NMR-Imaging GmbH with 1 ClinicalTrials.gov record(s).