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NCT05104866 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 732
- Enrollment target
- 20
- Study locations
NCT05104866: Active Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
NCT05104866 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 732 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05104866, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 732 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) 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.
Primary Outcome
PFS is defined as time from randomization until progression per RECIST 1.1, as assessed by BICR, or death due to any cause. The analysis will include all randomized participants as randomized regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Gemcitabine
- DRUG Eribulin
- DRUG Dato-DXd
- DRUG Vinorelbine
Study Locations (20)
Other
- Research Site - CABA
- Research Site - Ciudad de Buenos Aires
- Research Site - La Plata
- Research Site - Mar del Plata
- Research Site - Rosario
- Research Site - Rosario
California
- Research Site - Duarte
- Research Site - Los Angeles
- Research Site - Palo Alto
- Research Site - San Francisco
Massachusetts
- Research Site - Boston
- Research Site - Boston
Florida
- Research Site - Jacksonville
Georgia
- Research Site - Atlanta
Michigan
- Research Site - Grand Rapids
New York
- Research Site - New York
Ohio
- Research Site - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 732 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 3 |
What the registry record for NCT05104866 still lists
NCT05104866 is an interventional study that assigns participants to a tested intervention. The registered 732 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05104866 names 20 study sites across 11 states, led by Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05104866 about?
NCT05104866 is a clinical study titled "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)". The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-...
What is the current status of trial NCT05104866?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 732 participants. The study started on 2021-10-18. Estimated completion is 2026-07-31.
What conditions does trial NCT05104866 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05104866?
The interventions under investigation include: Capecitabine (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Dato-DXd (DRUG), Vinorelbine (DRUG).
Who is sponsoring clinical trial NCT05104866?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05104866 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05104866's enrollment target sits among peer trials
732 155th of 1224 higher than 1,070 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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