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NCT06112379 · ClinicalTrials.gov registry record · Phase 3
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 1,902
- Enrollment target
- 20
- Study locations
NCT06112379 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,902 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT06112379, 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
- 1,902 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Doxorubicin
- DRUG Durvalumab
- DRUG Dato-DXd
- DRUG Epirubicin
Study Locations (20)
California
- Research Site - Los Angeles
- Research Site - Santa Barbara
- Research Site - Santa Rosa
- Research Site - Torrance
Florida
- Research Site - Fort Myers
- Research Site - Jacksonville
- Research Site - St. Petersburg
- Research Site - West Palm Beach
Arkansas
- Research Site - Jonesboro
- Research Site - Rogers
Colorado
- Research Site - Aurora
- Research Site - Longmont
Connecticut
- Research Site - Bridgeport
- Research Site - New Haven
Kentucky
- Research Site - Edgewood
- Research Site - Louisville
Alabama
- Research Site - Daphne
Arizona
- Research Site - Prescott
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,902 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2032-09-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06112379
The ClinicalTrials.gov registry entry for NCT06112379 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,902 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 (32% 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 Pembrolizumab is the first listed.
NCT06112379 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06112379 about?
NCT06112379 is a clinical study titled "A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer". This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembroli...
What is the current status of trial NCT06112379?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,902 participants. The study started on 2023-11-14. Estimated completion is 2032-09-23.
What conditions does trial NCT06112379 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06112379?
The interventions under investigation include: Pembrolizumab (DRUG), Doxorubicin (DRUG), Durvalumab (DRUG), Dato-DXd (DRUG), Epirubicin (DRUG).
Who is sponsoring clinical trial NCT06112379?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06112379 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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.