Table 3.

Ongoing studies evaluating T-DM1 combined with other drugs in BC

Trial	Agents	Phase	Number of patients	Patients	Primary endpoint
NCT05673928 (TUCATEMEB)	Tucatinib in combination with T-DM1	II	30	Metastatic HER2-positive cancers	Intracranial antitumor activity
NCT04873362 (Astefania)	T-DM1 + placebo or atezolizumab	III	1,700	HER2-positive BC with high risk of relapse in the adjuvant setting	IDFS
NCT04457596 (CompassHER2 RD)	T-DM1 + placebo or tucatinib	III	1,031	HER2-positive BC with residual disease following neoadjuvant HER2-based treatment	IDFS
NCT05560308	T-DM1 + pyrotinib maleate	II	50	HER2+ MBC after progression on TKI	ORR

T-DM1: Tratsuzumab emtansine; BC: breast cancer; IDFS: invasive disease-free survival; MBC: metastatic breast cancer; TKI: tyrosine kinase inhibitor; ORR: overall response rate.