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NCT06103864 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 625
- Enrollment target
- 20
- Study locations
NCT06103864 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 625 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06103864, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 625 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG Durvalumab
- DRUG Dato-DXd
Study Locations (20)
California
- Research Site - Duarte
- Research Site - Glendale
- Research Site - Sacramento
- Research Site - Santa Rosa
Florida
- Research Site - Jacksonville
- Research Site - Miami
- Research Site - Palm Bay
- Research Site - Plantation
Illinois
- Research Site - Chicago
- Research Site - Decatur
- Research Site - Elmhurst
- Research Site - Naperville
Alabama
- Research Site - Daphne
Arkansas
- Research Site - Springdale
Colorado
- Research Site - Aurora
Connecticut
- Research Site - New Haven
Georgia
- Research Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 625 participants |
| Start Date | 2023-11-23 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06103864
The ClinicalTrials.gov registry entry for NCT06103864 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 625 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 (78% 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 Paclitaxel is the first listed.
NCT06103864 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06103864 about?
NCT06103864 is a clinical study titled "A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer". This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inope...
What is the current status of trial NCT06103864?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 625 participants. The study started on 2023-11-23. Estimated completion is 2030-09-30.
What conditions does trial NCT06103864 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06103864?
The interventions under investigation include: Paclitaxel (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Durvalumab (DRUG), Dato-DXd (DRUG).
Who is sponsoring clinical trial NCT06103864?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06103864 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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.