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Active, not recruiting Phase 3 Interventional

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

ClinicalTrials.gov ID: NCT04622319

Public ClinicalTrials.gov record NCT04622319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 19, 2026, 9:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

Study identification

NCT ID
NCT04622319
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
1,600 participants

Conditions and interventions

Interventions

  • DS-8201a Drug
  • T-DM1 Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 3, 2020
Primary completion
Jul 1, 2025
Completion
Jun 19, 2028
Last update posted
May 14, 2026

2020 – 2028

United States locations

U.S. sites
126
U.S. states
15
U.S. cities
97
Facility City State ZIP Site status
The Oncology Institute of Hope & Innovation Anaheim California 92801
Kaiser Permanente Anaheim California 92806
Kaiser Permanente Baldwin Park California 91706
Kaiser Permanente Bellflower California 90706
Kaiser Permanente Fontana California 92335
Orange Coast Blood and Cancer Care Fountain Valley California 92708
Kaiser Permanente Harbor City California 90710
Kaiser Permanente Irvine California 92618
Long Beach Memorial TCI Long Beach California 90806
Kaiser Permanente Los Angeles California 90027
Kaiser Permanente Ontario California 90710
Kaiser Permanente Panorama City California 91402
Kaiser Permanente Riverside California 92505
Kaiser Permanente San Diego California 92120
Kaiser Permanente San Marcos California 92078
Kaiser Permanente West Los Angeles California 90034
Kaiser Permanente Woodland Hills California 91367
SCRI FCS North- Altamonte Altamonte Springs Florida 32701
SCRI FCS South- Bonita Bonita Springs Florida 34135
SCRI FCS North- Brandon Cancer Center Brandon Florida 33511
SCRI FCS South- North Fort Myers Cape Coral Florida 33909
SCRI FCS North- Mease/Clearwater Clearwater Florida 33761
SCRI FCS South Fort Myers Florida 33901
SCRI FCS South- Colonial Fort Myers Florida 33905
SCRI FCS South- Gladiolus Fort Myers Florida 33908
SCRI FCS North- Gainesville Cancer Center Gainesville Florida 32605
Baptist MD Anderson Cancer Center Jacksonville Florida 32207
SCRI FCS North- Villages East Lady Lake Florida 32159
SCRI FCS South- Lakewood Ranch Lakewood Rch Florida 34211
SCRI FCS North- Largo/Highland Largo Florida 33770
SCRI FCS North- Lecanto Lecanto Florida 34461
SCRI FCS South- Naples West Naples Florida 34102
SCRI FCS South- Naples/Goodlette Naples Florida 34119
SCRI FCS North- New Port Richey New Port Richey Florida 34655
SCRI FCS North- Ocala Ocala Florida 34474
Orlando Health Ocoee Florida 34761
SCRI FCS North- Orange City Orange City Florida 32763
Orlando Health Orlando Florida 32806
SCRI FCS North- Orlando Downtown Orlando Florida 32806
SCRI FCS South- Port Charlotte Port Charlotte Florida 33980
SCRI FCS South- Sarasota-Cattleman Sarasota Florida 34232
SCRI FCS South-Sarasota-Downtown Sarasota Florida 34236
SCRI FCS North- Spring Hill Spring Hill Florida 34608
SCRI FCS North- St. Anthony's/St. Petersburg St. Petersburg Florida 33705
SCRI FCS North St. Petersburg Florida 33705
SCRI FCS North- Tampa Cancer Center Tampa Florida 33607
SCRI FCS North- Tavares Tavares Florida 32778
SCRI FCS South- Venice Healthpark Venice Florida 34292
Cleveland Clinic-Weston Weston Florida 33326
SCRI FCS North- Winter Park Winter Park Florida 32792
Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center Elmhurst Illinois 60126
Edward Cancer Center Naperville Illinois 60540
Edward Cancer Center Plainfield Plainfield Illinois 60585
University of Kentucky, Markey Cancer Center, Clinical Research Organization Lexington Kentucky 40536
Baptist Health Louisville Louisville Kentucky 40207
LSU Health Baton Rouge North Clinic Baton Rouge Louisiana 70805
Our Lady of the Lake Physician Group-Medical Oncology Baton Rouge Louisiana 70808
Mary Bird Perkins Cancer Center Baton Rouge Louisiana 70809
Ochsner Hematology Oncology North Shore - Covington (West Region) Covington Louisiana 70433
Ochsner Clinic Foundation New Orleans Louisiana 70121
MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute Baltimore Maryland 21237
MedStar Franklin Square Cancer Center at Loch Raven Campus Baltimore Maryland 21239
Frederick Health-James M Stockman Cancer Center Frederick Maryland 21702
Maryland Oncology Hematology Silver Spring Maryland 20904
Holy Cross Hospital Silver Spring Maryland 20910
Montefiore Medical Center The Bronx New York 10461
Waverly Hematology Oncology Cary North Carolina 27518
UNC Cancer Care at Nash Rocky Mount North Carolina 27804
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157
Cleveland Clinic - Hillcrest Cleveland Ohio 44195
Cleveland Clinic-Fairview Cleveland Ohio 44195
Cleveland Clinic Cleveland Ohio 44195
Cleveland Clinic South Pointe Warrensville Heights Ohio 44195
UPMC Upper St. Clair Bethel Park Pennsylvania 15102
UPMC Passavant Cranberry/North Cranberry Township Pennsylvania 16066
UPMC Erie Erie Pennsylvania 16505
AHN Cancer Inst at St Vincent Erie Pennsylvania 16544
UPMC Arnold Palmer-Mt View Greensburg Pennsylvania 15601
UPMC Pinnacle-Ortenzio Cancer Center Harrisburg Pennsylvania 17050
UMPC Pinnacle Pharmacy Harrisburg Pennsylvania 17109
AHN Cancer Insititute at Jefferson Jefferson Hills Pennsylvania 15025
AHN Cancer Institute at Forbes Monroeville Pennsylvania 15146
UPMC Monroeville Monroeville Pennsylvania 15146
UPMC Arnold Palmer-Mt Pleasant Mount Pleasant Pennsylvania 15666
UPMC Arnold Palmer-Norwin N. Huntingdon Pennsylvania 15642
Allegheny General Hospital Pittsburgh Pennsylvania 15212
Magee Pittsburgh Pennsylvania 15213
UPMC St. Margaret Pittsburgh Pennsylvania 15215
AHN Cancer Inst at West Penn Pittsburgh Pennsylvania 15224
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232
UPMC Passavant HOA Pittsburgh Pennsylvania 15237
UPMC Passavant OHA Pittsburgh Pennsylvania 15237
UPMC Uniontown Uniontown Pennsylvania 15401
UPMC Washington Washington Pennsylvania 15301
Reading Hospital, McGlinn Cancer Institute West Reading Pennsylvania 19611
AHN Cancer Institute at Wexford Wexford Pennsylvania 15090
UPMC Pinnacle-Memorial Cancer Center York Pennsylvania 17408
SCRI TO Nashville- Franklin Tennessee Oncology, PLLC Franklin Tennessee 37067
SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC Gallatin Tennessee 37066
SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC Hendersonville Tennessee 37075
SCRI TO Nashville- Summit Tennessee Oncology, PLLC Hermitage Tennessee 37076
Regional Cancer Center at Indian Path Community Hospital Kingsport Tennessee 37660
SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC Lebanon Tennessee 37090
SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLC Nashville Tennessee 37203
Tennessee Oncology Nashville / Sarah Cannon Nashville Tennessee 37203
SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC Nashville Tennessee 37205
SCRI TO Nashville- Skyline Tennessee Oncology, PLLC Nashville Tennessee 37207
SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLC Nashville Tennessee 37211
SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC Smyrna Tennessee 37167
Houston Methodist Baytown Baytown Texas 77521
Houston Methodist Houston Texas 77030
Houston Methodist Willowbrook Houston Texas 77070
Houston Methodist West Houston Texas 77094
Houston Methodist Clear Lake Nassau Bay Texas 77058
Houston Methodist Sugarland Sugar Land Texas 77479
Houston Methodist Woodlands The Woodlands Texas 77385
Wellmont Medical Associates Oncology & Hematology Bristol Virginia 24201
University of Virginia Charlottesville Virginia 22908
Virginia Commonwealth University Massey Cancer Center Richmond Virginia 23298
MultiCare Cancer Center Aurburn Auburn Washington 98002
MultiCare Regional Cancer Center - Gig Harbor Gig Harbor Washington 98335
MultiCare Cancer Center Puyallup Puyallup Washington 98372
MultiCare Institute for Research & Innovation Spokane Washington 99204
MultiCare Institute for Research & Innovation Spokane Washington 99218
MultiCare Cancer Center Tacoma Tacoma Washington 98405
West Virginia University Morgantown West Virginia 26506

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 356 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04622319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 14, 2026 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04622319 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →