A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
Public ClinicalTrials.gov record NCT05104866. 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.
Study identification
- NCT ID
- NCT05104866
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AstraZeneca
- Industry
- Enrollment
- 732 participants
Conditions and interventions
Conditions
Interventions
- Capecitabine Drug
- Dato-DXd Drug
- Eribulin Drug
- Gemcitabine Drug
- Vinorelbine 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
- Oct 17, 2021
- Primary completion
- Jul 23, 2024
- Completion
- Jul 30, 2026
- Last update posted
- May 4, 2026
2021 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | — |
| Research Site | Los Angeles | California | 90095 | — |
| Research Site | Palo Alto | California | 94305-5826 | — |
| Research Site | San Francisco | California | 94143 | — |
| Research Site | Jacksonville | Florida | 32207 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | Grand Rapids | Michigan | 49503 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Cleveland | Ohio | 44119 | — |
| Research Site | Portland | Oregon | 97239 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Richmond | Virginia | 23219 | — |
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 153 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05104866, 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 4, 2026 · Synced May 8, 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 protocol, eligibility criteria, and contact information for NCT05104866 live on ClinicalTrials.gov.