NCT03523585

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Type	Name	Description
DRUG	Trastuzumab deruxtecan	DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
DRUG	Capecitabine	Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
DRUG	Lapatinib	Investigator's choice Standard of Care when combined with capecitabine
DRUG	Trastuzumab	Investigator's choice Standard of Care when combined with capecitabine

Timeline

• Start date: 2018-08-01
• Primary completion: 2022-06-30
• Completion: 2025-12-23
• First posted: 2018-05-14
• Last updated: 2026-02-27
• Results posted: 2023-06-26

Locations

227 sites across 15 countries: United States, Australia, Belgium, Brazil, Czechia, France, Germany, Greece, Israel, Italy, Japan, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study