NCT03734029|Active Not RecruitingPhase 3ResultsDMCFDA Drug

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

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Daiichi Sankyo ClinicalTrials.gov

Compare

4 other identifiers

DS8201-A-U3032018-003069-33184223DESTINY-B04

Study Type

interventional

Target

557

Locations

20 countries

Sites

208

Timeline

RegisteredNov 2018

StartedDec 2018

CompletionAug 2026

Brief 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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Strong global presence with extensive site network

Enrollment

557

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline

Completed

Started Dec 2018

Typical duration for phase_3 breast-cancer

Geographic Reach

20 countries

208 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.6 years study duration

First Submitted

Initial submission to the registry

November 6, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

December 27, 2018

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2022

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

June 15, 2023

Completed

3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

November 6, 2018

Results QC Date

January 11, 2023

Last Update Submit

September 16, 2025

Conditions

Breast Cancer

Keywords

Anti-HER2-Antibody Drug Conjugate (ADC)Unresectable or MetastaticHuman epidermal growth factor receptor 2 (HER2)-lowDESTINY - Breast 04

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years

Secondary Outcomes (10)

Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)
From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Number of Overall Survival Events (Deaths)
From the date of randomization up to the date of death due to any cause, up to approximately 3 years
+5 more secondary outcomes

Other Outcomes (1)

All-Cause Mortality
From the date of randomization up to the date of death due to any cause, up to approximately 3 years

Study Arms (2)

Trastuzumab deruxtecan

EXPERIMENTAL

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a

Drug: Trastuzumab deruxtecan (DS-8201a)

Physician's Choice

ACTIVE COMPARATOR

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: * Capecitabine * Eribulin * Gemcitabine * Paclitaxel * Nab-paclitaxel

Drug: CapecitabineDrug: EribulinDrug: GemcitabineDrug: PaclitaxelDrug: Nab-paclitaxel

Interventions

Trastuzumab deruxtecan (DS-8201a)DRUG

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

Also known as: DS-8201a

Trastuzumab deruxtecan

CapecitabineDRUG