MedTrace Logo

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

NCT03529110 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2025-10-21

Study results available
· View outcomes & findings →

Summary

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Conditions

Interventions

DRUG

Trastuzumab deruxtecan (T-DXd)

T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.

DRUG

Ado-trastuzumab emtansine (T-DM1)

The treatment will be in accordance with the approved label.

Sponsors & Collaborators

Principal Investigators

  • Global Team Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-09
Primary Completion
2021-05-21
Completion
2026-07-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529110 on ClinicalTrials.gov