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NCT05629585 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 1,174
- Enrollment target
- 20
- Study locations
NCT05629585 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,174 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT05629585, 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
- 1,174 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Capecitabine
- DRUG Durvalumab
- DRUG Dato-DXd
Study Locations (20)
California
- Research Site - Beverly Hills
- Research Site - Costa Mesa
- Research Site - Duarte
- Research Site - Fountain Valley
- Research Site - Irvine
- Research Site - La Jolla
- Research Site - Lakewood
- Research Site - Los Angeles
- Research Site - Los Angeles
- Research Site - Newport Beach
- Research Site - Newport Beach
- Research Site - Orange
- Research Site - Roseville
- Research Site - Upland
Arizona
- Research Site - Gilbert
- Research Site - Tucson
- Research Site - Tucson
Arkansas
- Research Site - Hot Springs
- Research Site - Little Rock
- Research Site - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,174 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2030-01-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05629585
The ClinicalTrials.gov registry entry for NCT05629585 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT05629585 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05629585 about?
NCT05629585 is a clinical study titled "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)". 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 surgica...
What is the current status of trial NCT05629585?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,174 participants. The study started on 2022-11-28. Estimated completion is 2030-01-30.
What conditions does trial NCT05629585 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05629585?
The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), Durvalumab (DRUG), Dato-DXd (DRUG).
Who is sponsoring clinical trial NCT05629585?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05629585 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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