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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: Recruiting Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The comparison will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anticancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at
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 |
What NCT06103864 shows while recruiting
NCT06103864 is an interventional study that assigns participants to a tested intervention. The registered 625 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 (78% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT06103864's enrollment target sits among peer trials
625 171st of 1224 higher than 1,053 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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