NCT03529110

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]

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-09
• Primary completion: 2021-05-21
• Completion: 2026-07-30
• First posted: 2018-05-18
• Last updated: 2025-10-21
• Results posted: 2022-04-29

Locations

164 sites across 15 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study