Table 2.

Summary of ongoing clinical trials exploring the role of Dato-DXd as monotherapy or in combination with other anticancer agents.

NCT Number/Trial name	Trial Design/Patient Population	Characteristic	Number of pts	Intervention	Primary endpoint
NCT05460273, TROPION-PanTumor02	Phase 1/Phase 2 trial assessing the efficacy and safety of Dato-DXd in inoperable locally advanced or metastatic TNBC in Chinese population (N = 15)	Multicentre, open-label, multiple-cohort study, which is designed to evaluate the efficacy, safety, Pharmacokinetic, and immunogenicity of Dato-DXd in adult Chinese participants compared with ICC in inoperable locally advanced or metastatic TNBC who have received at least 2 prior chemotherapy regimens	118	Drug: Datopotamab Deruxtecan (Dato-DXd)	Efficacy and safety
NCT05104866, TROPION-Breast01	Phase 3 evaluate the safety and efficacy of Dato-DXd in participants with inoperable or metastatic TNBC	Open-label, randomized study of Dato-DXd versus investigator's choice of chemotherapy in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy	733	Drug: Dato-DXd Drug: Capecitabine Drug: Gemcitabine Drug: Eribulin Drug: Vinorelbine	PFS and OS
NCT05374512, TROPION-Breast02	Phase-3 evaluate the safety and efficacy in TNBC Not Candidates for PD-1/PD-L1 Inhibitor Therapy	Randomized, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd	600	Drug: Dato-DXd Drug: Paclitaxel Drug: Nab-paclitaxel Drug: CarboplatinDrug: Capecitabine Drug: Eribulin mesylate	PFS and OS
NCT05629585, TROPION-Breast03	Phase 3, demonstrate superiority of Dato-DXd in combination with durvalumab in stage I to III TNBC	Randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy	1075	Drug: Dato-DXd Drug: Durvalumab Drug: Capecitabine Drug: Pembrolizumab	Superiority of Dato-DXd in combination with durvalumab