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Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2025-10-06

Study results available
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Summary

This study will compare DS-8201a to physician choice standard treatment.

Participants must have HER2-low breast cancer that has been treated before.

Participants' cancer:

* Cannot be removed by an operation
* Has spread to other parts of the body

Conditions

Interventions

DRUG

Trastuzumab deruxtecan (DS-8201a)

DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously

DRUG

Capecitabine

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Eribulin

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Gemcitabine

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Paclitaxel

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Nab-paclitaxel

Administered according to label, as one option for Physician's Choice (determined before randomization)

Sponsors & Collaborators

Principal Investigators

  • Global Clinical 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
2018-12-27
Primary Completion
2022-01-11
Completion
2026-08-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT03734029 on ClinicalTrials.gov