A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
Public ClinicalTrials.gov record NCT05629585. 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 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
Study identification
- NCT ID
- NCT05629585
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,174 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- 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
- Nov 28, 2022 (Actual)
- Primary completion
- Sep 1, 2027 (Estimated)
- Completion
- Feb 28, 2030 (Estimated)
- Last update posted
- Oct 14, 2026
2022 – 2030
United States locations
- U.S. sites
- 88
- U.S. states
- 30
- U.S. cities
- 73
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Gilbert | Arizona | 85234 | — |
| Research Site | Tucson | Arizona | 85711 | — |
| Research Site | Tucson | Arizona | 85719 | — |
| Research Site | Hot Springs | Arkansas | 71913 | — |
| Research Site | Little Rock | Arkansas | 72205 | — |
| Research Site | Springdale | Arkansas | 72762 | — |
| Research Site | Beverly Hills | California | 90211 | — |
| Research Site | Costa Mesa | California | 92627 | — |
| Research Site | Duarte | California | 91010 | — |
| Research Site | Fountain Valley | California | 92708 | — |
| Research Site | Irvine | California | 92618 | — |
| Research Site | La Jolla | California | 92093 | — |
| Research Site | Lakewood | California | 90805 | — |
| Research Site | Los Angeles | California | 90017 | — |
| Research Site | Los Angeles | California | 90095 | — |
| Research Site | Newport Beach | California | 92660 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Orange | California | 92868 | — |
| Research Site | Roseville | California | 95661 | — |
| Research Site | Upland | California | 91786 | — |
| Research Site | Vallejo | California | 94589 | — |
| Research Site | Denver | Colorado | 80220 | — |
| Research Site | New Haven | Connecticut | 06510 | — |
| Research Site | Newark | Delaware | 19713 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Altamonte Springs | Florida | 32701 | — |
| Research Site | Hollywood | Florida | 33021 | — |
| Research Site | Miami Beach | Florida | 33140 | — |
| Research Site | Tallahassee | Florida | 32308 | — |
| Research Site | West Palm Beach | Florida | 33401 | — |
| Research Site | Athens | Georgia | 30607 | — |
| Research Site | Atlanta | Georgia | 30318 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Chicago | Illinois | 60611 | — |
| Research Site | Maywood | Illinois | 60153 | — |
| Research Site | Westwood | Kansas | 66205 | — |
| Research Site | Lexington | Kentucky | 40503 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | Louisville | Kentucky | 40207 | — |
| Research Site | Louisville | Kentucky | 40241 | — |
| Research Site | New Orleans | Louisiana | 70121 | — |
| Research Site | Annapolis | Maryland | 21401 | — |
| Research Site | Baltimore | Maryland | 21202 | — |
| Research Site | Columbia | Maryland | 21044 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Detroit | Michigan | 48201 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | Camden | New Jersey | 08103 | — |
| Research Site | Albuquerque | New Mexico | 87109 | — |
| Research Site | New York | New York | 10011 | — |
| Research Site | New York | New York | 10021 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | New York | New York | 10032 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Charlotte | North Carolina | 28204 | — |
| Research Site | Canton | Ohio | 44710 | — |
| Research Site | Cleveland | Ohio | 44106 | — |
| Research Site | Cleveland | Ohio | 44111 | — |
| Research Site | Cleveland | Ohio | 44195 | — |
| Research Site | Columbus | Ohio | 43219 | — |
| Research Site | Portland | Oregon | 97227 | — |
| Research Site | Hershey | Pennsylvania | 17033 | — |
| Research Site | Philadelphia | Pennsylvania | 19111 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | Providence | Rhode Island | 02903 | — |
| Research Site | Germantown | Tennessee | 38138 | — |
| Research Site | Memphis | Tennessee | 38120 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Nashville | Tennessee | 37232 | — |
| Research Site | Bedford | Texas | 76022 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
| Research Site | Houston | Texas | 77024 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Irving | Texas | 75063 | — |
| Research Site | McAllen | Texas | 78503 | — |
| Research Site | Tyler | Texas | 75702 | — |
| Research Site | Fairfax | Virginia | 22031 | — |
| Research Site | Midlothian | Virginia | 23114 | — |
| Research Site | Norfolk | Virginia | 23502 | — |
| Research Site | Reston | Virginia | 20190 | — |
| Research Site | Edmonds | Washington | 98026 | — |
| Research Site | Issaquah | Washington | 98029 | — |
| Research Site | Puyallup | Washington | 98373 | — |
| Research Site | Seattle | Washington | 98104 | — |
| Research Site | Seattle | Washington | 98133 | — |
| Research Site | Spokane Valley | Washington | 99216 | — |
| Research Site | 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 188 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05629585, 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 Oct 14, 2026 · Synced Oct 26, 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 NCT05629585 live on ClinicalTrials.gov.