DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
This completed study (DESTINY-Breast02) compared trastuzumab deruxtecan with standard treatment in people with HER2-positive breast cancer that had spread and had already been treated with trastuzumab emtansine. It measured how long the cancer stayed under control.
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
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
+Read the 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.
- Breast Cancer
- Trastuzumab deruxtecan
- Capecitabine
- Lapatinib
- Trastuzumab
- Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine — Baseline up to 46 months postdose
Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.
- Acıbadem Adana Hospital, Adana
Also running at 226 other sites in 15 countries.
Source: ClinicalTrials.gov NCT03523585 · last updated 2026-02-27 · View registry record ↗