7 JCI-accredited hospitals 17 hospitals with oncology 65 oncology specialists 19 clinical trials recruiting
Oncology & Cancer Care
CompletedPhase 3NCT03523585

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.

SponsorDaiichi Sankyo
Study typeInterventional
Started2018-08-01
Primary completion2022-06-30
Planned enrolment608
Sites1 Acıbadem · 226 other

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

What this study is about

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.

Conditions
  • Breast Cancer
Interventions
  • Trastuzumab deruxtecan
  • Capecitabine
  • Lapatinib
  • Trastuzumab
Primary outcome measures
  • 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
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
Inclusion
* Is the age of majority in their country * Has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory 3. was previously treated with ado-trastuzumab emtansine (T-DM1) * Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy) * Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy. * Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least: 1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) 2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants) 3. 7 months after the last dose of trastuzumab/capecitabine * Has adequate hematopoietic, renal and hepatic functions
Exclusion
* Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy * Has had prior treatment with capecitabine * Has uncontrolled or significant cardiovascular disease * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening * Has active central nervous system (CNS) metastases

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • 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 ↗