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

NCT03523585 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2026-02-27

Study results available
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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

Conditions

Interventions

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

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
2018-08-01
Primary Completion
2022-06-30
Completion
2025-12-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03523585 on ClinicalTrials.gov