TROPION-Breast02 — Datopotamab deruxtecan versus investigator's choice of chemotherapy in first-line, PD-L1-low, inoperable or metastatic triple-negative breast cancer (TROPION-Breast02)

Phase 3 · Breast Cancer, Triple-Negative Breast Cancer

Population

Treatment-naïve, locally recurrent inoperable or metastatic triple-negative breast cancer not eligible for PD-1/PD-L1 inhibitor therapy (PD-L1-low).

Primary Endpoint

Progression-free survival and overall survival

Rationale

TROP2-directed antibody-drug conjugates are active in pretreated triple-negative breast cancer, but frontline options for PD-L1-low disease remain chemotherapy. TROPION-Breast02 tests whether datopotamab deruxtecan can replace first-line chemotherapy as a targeted alternative.

What It Could Change

Could establish a TROP2-directed antibody-drug conjugate as a first-line, chemotherapy-sparing standard for PD-L1-low metastatic triple-negative breast cancer.