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NCT05113251 · ClinicalTrials.gov registry record · Phase 3
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
A Phase 3 study of Breast Cancer and Breast Neoplasms, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 927
- Enrollment target
- 20
- Study locations
NCT05113251: Active Phase 3 study of Breast Cancer and Breast Neoplasms, sponsored by AstraZeneca.
NCT05113251 is a Phase 3 study of Breast Cancer and Breast Neoplasms that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 927 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05113251, a Phase 3 study of Breast Cancer and Breast Neoplasms, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 927 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
Primary Outcome
Proportion of participants who have no evidence by Hematoxylin \& Eosin (H\&E) staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoadjuvant therapy.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Trastuzumab Deruxtecan
- DRUG Pertuzumab
Study Locations (20)
California
- Research Site - Beverly Hills
- Research Site - Glendale
- Research Site - Los Alamitos
- Research Site - Orange
Kentucky
- Research Site - Lexington
- Research Site - Louisville
New Jersey
- Research Site - East Brunswick
- Research Site - Summit
Tennessee
- Research Site - Germantown
- Research Site - Nashville
Arkansas
- Research Site - Springdale
Connecticut
- Research Site - New Haven
Indiana
- Research Site - Fort Wayne
Louisiana
- Research Site - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 927 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 3 |
What the registry record for NCT05113251 still lists
NCT05113251 is an interventional study that assigns participants to a tested intervention. The registered 927 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 (67% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT05113251 names 20 study sites across 14 states, led by California, Kentucky, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05113251 about?
NCT05113251 is a clinical study titled "Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer". This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
What is the current status of trial NCT05113251?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 927 participants. The study started on 2021-10-25. Estimated completion is 2027-04-30.
What conditions does trial NCT05113251 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms, HER2-positive Early Breast Cancer.
What interventions are being tested in trial NCT05113251?
The interventions under investigation include: Trastuzumab (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Trastuzumab Deruxtecan (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT05113251?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05113251 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Indiana, Kentucky. 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 NCT05113251's enrollment target sits among peer trials
927 134th of 1224 higher than 1,091 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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