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Clinical trial · no report yet · Phase 3

NCT03523585

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
Podcasts14
X threads14
YouTube12

The trial

ClinicalTrials.gov
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
Phase
Phase 3
Status
Completed
Conditions
Breast Cancer
Interventions
Trastuzumab deruxtecan; Capecitabine; Lapatinib; Trastuzumab
Arms
  • Trastuzumab deruxtecan (DS-8201a) · Experimental
  • Trastuzumab+capecitabine · Active comparator
  • Lapatinib+capecitabine · Active comparator
Enrollment
608
Primary outcomes
  • 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
Sponsor
Daiichi Sankyo with Daiichi Sankyo Co., Ltd., AstraZeneca
Start
Aug 1, 2018
Primary completion
Jun 30, 2022
Results posted
Yes
Registry record
NCT03523585 · updated Feb 27, 2026

Publications

linked from the registry
  • Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20. PubMed 37086745
  • Fehm T, Cottone F, Dunton K, Andre F, Krop I, Park YH, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego MR, Yerushalmi R, Duhoux FP, Takano T, Lu W, Egorov A, Kim SB. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 May;25(5):614-625. doi: 10.1016/S1470-2045(24)00128-1. PubMed 38697155