Table 4.

Exploratory endpoints.

TROPION-Breast03 exploratory endpoints

Exploratory endpoints • IBCFS* of Dato-DXd monotherapy versus ICT • IBCFS of Dato-DXd + durvalumab versus ICT • Patient-reported outcomes • Fertility status • Association of TROP2, PD-L1, or other tumor-derived biomarkers with response and tolerability to investigative regimens • Association of exploratory biomarkers in the tumor, plasma, whole blood, or serum collected before, during treatment, or at disease progression with disease status and/or response and tolerability to Dato-DXd ± durvalumab • Assessment of ctDNA dynamic changes as an indicator for recurrence on Dato-DXd ± durvalumab • Assessment of molecular and genomic determinants of response/resistance to Dato-DXd ± durvalumab in tumor and blood • To explore the impact of treatment and disease on healthcare resource use

^*IBCSF is defined as time from randomization until the date of the first occurrence of one of the following: ipsilateral invasive breast tumor (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; or death from any cause.

ctDNA, circulating tumor DNA; Dato-DXd, datopotamab deruxtecan; IBCFS, invasive breast cancer free survival; ICT, investigator’s choice of therapy; PD-L1, programmed cell death ligand-1; TROP2, trophoblast cell-surface antigen 2.