DESTINY-Breast04 — Trastuzumab Deruxtecan vs Physician's Choice Chemotherapy in HER2-Low Metastatic Breast Cancer

Phase 3 · 2022 · Breast Cancer

Design

Randomized 2:1 to trastuzumab deruxtecan vs physician's choice single-agent chemotherapy in previously treated HER2-low disease.

Population

Metastatic HER2-low (IHC 1+ or 2+/ISH-) breast cancer, hormone-receptor positive or negative, after prior chemotherapy.

Primary Endpoint

progression-free survival (PFS) in HR-positive patients

Key Result

Overall cohort: OS 23.4 vs 16.8 mo (HR 0.64), PFS 9.9 vs 5.1 mo (HR 0.50); HR+ cohort PFS 10.1 vs 5.4 mo (HR 0.51).

Guideline Impact

NCCN category 1 for HER2-low metastatic breast cancer