Available in Spain, Mexico, United States, Argentina
The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab
relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants
with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd
monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history
(de novo vs. prior DFI 6 to 12 months vs. prior DFI > 12 months), and prior PD-1/PD-L1
treatment for early stage TNBC (yes vs. no).
This study aims to see if Dato-DXd with durvalumab allows patients to live longer without
their breast cancer getting worse, or simply to live longer, compared to patients
receiving standard of care chemotherapy and pembrolizumab. This study is also looking to
see how the treatment and the breast cancer affects patients' quality of life.
7Research sites
625Patients around the world