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NCT04739761 · ClinicalTrials.gov registry record · Phase 3
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
- 20
- Study locations
NCT04739761: Active Phase 3 study of Breast Cancer, sponsored by AstraZeneca.
NCT04739761 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 506 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04739761, 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
- 506 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Primary Outcome
The ORR is defined as the percentage (%) of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Conditions Studied
Interventions
- DRUG Trastuzumab Deruxtecan
Study Locations (20)
Other
- Research Site - Adelaide
- Research Site - Auchenflower
- Research Site - Clayton
- Research Site - Heidelberg
- Research Site - St Leonards
- Research Site - Subiaco
- Research Site - Anderlecht
- Research Site - Bruges
- Research Site - Leuven
- Research Site - Liège
- Research Site - Copenhagen
- Research Site - Herlev
- Research Site - Odense C
- Research Site - Helsinki
- Research Site - Tampere
- Research Site - Turku
Massachusetts
- Research Site - Boston
North Carolina
- Research Site - Durham
British Columbia
- Research Site - Vancouver
Ontario
- Research Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2026-05-26 |
| Phase | Phase 3 |
What the registry record for NCT04739761 still lists
NCT04739761 is an interventional study that assigns participants to a tested intervention. The registered 506 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 (82% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab Deruxtecan is the first listed.
NCT04739761 names 20 study sites across 5 states, led by Other, Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04739761 about?
NCT04739761 is a clinical study titled "A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer". This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-ba...
What is the current status of trial NCT04739761?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2021-06-22. Estimated completion is 2026-05-26.
What conditions does trial NCT04739761 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04739761?
The interventions under investigation include: Trastuzumab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT04739761?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04739761 being conducted?
This trial has 20 study locations across Massachusetts, North Carolina, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04739761's enrollment target sits among peer trials
506 192nd of 1224 higher than 1,033 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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