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NCT05374512 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
- 20
- Study locations
NCT05374512 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 644 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT05374512, 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
- 644 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- DRUG Dato-DXd
Study Locations (20)
California
- Research Site - Duarte
- Research Site - Los Angeles
- Research Site - San Francisco
Colorado
- Research Site - Grand Junction
- Research Site - Longmont
Florida
- Research Site - Miami
- Research Site - Miami
North Carolina
- Research Site - Charlotte
- Research Site - Winston-Salem
Tennessee
- Research Site - Memphis
- Research Site - Nashville
Connecticut
- Research Site - New Haven
District of Columbia
- Research Site - Washington D.C.
Georgia
- Research Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2022-05-16 |
| Est. Completion | 2028-11-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05374512
The ClinicalTrials.gov registry entry for NCT05374512 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 644 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (77% 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 5 interventions - of which Carboplatin is the first listed.
NCT05374512 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT05374512 about?
NCT05374512 is a clinical study titled "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)". 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.
What is the current status of trial NCT05374512?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2022-05-16. Estimated completion is 2028-11-03.
What conditions does trial NCT05374512 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05374512?
The interventions under investigation include: Carboplatin (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Dato-DXd (DRUG).
Who is sponsoring clinical trial NCT05374512?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05374512 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.