ClinicalTrials.gov record
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.
Study identification
- NCT ID
- NCT04622319
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,600 participants
Conditions and interventions
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 4, 2020 (Actual)
- Primary completion
- Jul 2, 2025 (Actual)
- Completion
- Jun 20, 2028 (Estimated)
- Last update posted
- May 15, 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 15, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04622319 live on ClinicalTrials.gov.