Enhertu (Trastuzumab deruxtecan, DNA topoisomerase I inhibitor; AstraZeneca, Daiichi Sankyo)
- This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan (T-DXd) compared to investigator’s choice of chemotherapy in HER2-low, HR+ve breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting
- Study design: Phase 3 (N= 850); PCD: Dec’22 (PFS ~60 months); Randomized, parallel assignment, open label and multi-centered (global) study
- Regimen:
- Arm 1: T-DXd monotherapy, IV infusion
- Arm 2: Investigator’s choice of chemotherapy (capecitabine (oral), paclitaxel (IV), nab-paclitaxel (IV))
- Patient segment:
- Advanced or metastatic HR+, HER2-low or -ve; Never previously HER2+ve
- Should not have had prior chemotherapy and should have progressed on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting or disease progression within 24 months of starting adjuvant endocrine therapy and on at least 1 previous line of endocrine therapy in the metastatic setting