A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)
Public ClinicalTrials.gov record NCT05374512. 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 (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
Study identification
- NCT ID
- NCT05374512
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 644 participants
Conditions and interventions
Conditions
Interventions
- Dato-DXd Drug
- Paclitaxel Drug
- Nab-paclitaxel Drug
- Carboplatin Drug
- Capecitabine Drug
- Eribulin mesylate 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
- May 16, 2022 (Actual)
- Primary completion
- Aug 25, 2025 (Actual)
- Completion
- Dec 31, 2026 (Estimated)
- Last update posted
- May 15, 2026
2022 – 2026
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | — |
| Research Site | Los Angeles | California | 90017 | — |
| Research Site | San Francisco | California | 94143 | — |
| Research Site | Grand Junction | Colorado | 81501 | — |
| Research Site | Longmont | Colorado | 80504 | — |
| Research Site | New Haven | Connecticut | 06510 | — |
| Research Site | Washington D.C. | District of Columbia | 20010 | — |
| Research Site | Miami | Florida | 33170 | — |
| Research Site | Miami | Florida | 33176 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Louisville | Kentucky | 40207 | — |
| Research Site | Detroit | Michigan | 48201 | — |
| Research Site | Albuquerque | New Mexico | 87109 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Charlotte | North Carolina | 28204 | — |
| Research Site | Winston-Salem | North Carolina | 27103 | — |
| Research Site | Providence | Rhode Island | 02903 | — |
| Research Site | Sioux Falls | South Dakota | 57105 | — |
| Research Site | Memphis | Tennessee | 38120 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Kingwood | Texas | 77339 | — |
| Research Site | San Antonio | Texas | 78240 | — |
| Research Site | Charlottesville | Virginia | 22908 | — |
| Research Site | Spokane Valley | Washington | 99216 | — |
| Research Site | Madison | Wisconsin | 53792 | — |
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 201 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05374512, 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 22, 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 NCT05374512 live on ClinicalTrials.gov.