clinical trial · NCT03523585
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Daiichi Sankyo·phase3·completed·n = 608
Breast CancerTrastuzumab deruxtecanCapecitabineLapatinibTrastuzumab
brief summary
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body
started
Aug 1, 2018
primary completion
Jun 30, 2022
completion
Dec 23, 2025
last updated
Feb 27, 2026
detailed description
The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.
official title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol