DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Public ClinicalTrials.gov record NCT03523585. 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 (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03523585
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 608 participants
Conditions and interventions
Conditions
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
- Aug 1, 2018 (Actual)
- Primary completion
- Jun 30, 2022 (Actual)
- Completion
- Dec 23, 2025 (Actual)
- Last update posted
- Feb 27, 2026
2018 – 2025
United States locations
- U.S. sites
- 41
- U.S. states
- 23
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer Research Centers | Chandler | Arizona | 85224 | — |
| UCLA Hematology Oncology - Main Site | Los Angeles | California | 90095 | — |
| Pacific Cancer Care | Monterey | California | 93940 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| Innovative Clinical Research Institute | Whittier | California | 90603 | — |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | — |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | — |
| Florida Cancer Specialists-Broadway | Fort Myers | Florida | 33901 | — |
| Piedmont Cancer Institute, PC | Atlanta | Georgia | 30318 | — |
| Kapiolani Medical Center for Women and Children/Univ of HI | Honolulu | Hawaii | 96826 | — |
| Loyola University Health System | Maywood | Illinois | 60153 | — |
| Community Hospital | Munster | Indiana | 46321 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | — |
| Maine Center for Cancer Medicine | Scarborough | Maine | 04074 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Cornell-Beshore Cancer Institute | Joplin | Missouri | 64804 | — |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | — |
| Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC | Kansas City | Missouri | 64132 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| North Shore Hematology Oncology Associates, PC | East Setauket | New York | 11733 | — |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | New York | New York | 10065 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | — |
| The Ohio State University | Columbus | Ohio | 43235 | — |
| Dayton Physicians, LLC | Kettering | Ohio | 45409 | — |
| Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15213 | — |
| Tennessee Oncology, PLLC Chattanooga | Chattanooga | Tennessee | 37404 | — |
| The West Clinic | Germantown | Tennessee | 38138 | — |
| SCRI - Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | — |
| Community Cancer Trials of Utah | Ogden | Utah | 84405 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| MultiCare Health System Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
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 186 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03523585, 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 Feb 27, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03523585 live on ClinicalTrials.gov.