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.
A Study of Dato-DXd Versus Investigator's Choice Chemotherapy
A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)
All genders
18+
Recruiting now
Overview
Principal Investigator: Ilana Schlam, MD
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Latoya Lashley
Study details
Inclusion Criteria
- Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC.
- No prior chemotherapy or targeted systemic therapy for metastatic or locally recurrent inoperable breast cancer.
- Not a candidate for PD-1/PD-L1 inhibitor therapy
Exclusion Criteria
- 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
- Persistent toxicities caused by previous anti cancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline
- 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.