This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
Inclusion Criteria
1. Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC.
2. No prior chemotherapy or targeted systemic therapy for metastatic or locally recurrent inoperable breast cancer.
3. Not a candidate for PD-1/PD-L1 inhibitor therapy
Exclusion Criteria
1. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence
2. Persistent toxicities caused by previous anti cancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline
3. Uncontrolled infection requiring IV antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
Study Requirements
The primary objectives of the study are to demonstrate superiority of Dato-DXd relative to ICC by assessment of PFS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, per BICR and to demonstrate superiority of Dato-DXd relative to ICC by assessment of OS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Participants will be randomised in a 1:1 ratio to one of two intervention groups.
