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NCT05288777 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
A Phase 2 study of Breast Cancer and Breast Cancer Stage II, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT05288777: Recruiting Phase 2 study of Breast Cancer and Breast Cancer Stage II, sponsored by University of Virginia.
NCT05288777 is a Phase 2 study of Breast Cancer and Breast Cancer Stage II that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 45 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05288777, a Phase 2 study of Breast Cancer and Breast Cancer Stage II, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.
Primary Outcome
Assessment of toxicity frequency and severity using CTCAE v5.0 adverse event grading scale throughout chemoradiation treatment and follow up.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG T-DM1
- RADIATION External Beam Radiation Therapy 0
- RADIATION External Beam Radiation Therapy 1
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-07-11 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What NCT05288777 shows while recruiting
NCT05288777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Capecitabine is the first listed.
NCT05288777 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05288777 about?
NCT05288777 is a clinical study titled "Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer". The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of thi...
What is the current status of trial NCT05288777?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2022-07-11. Estimated completion is 2029-12.
What conditions does trial NCT05288777 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage I.
What interventions are being tested in trial NCT05288777?
The interventions under investigation include: Capecitabine (DRUG), T-DM1 (DRUG), External Beam Radiation Therapy 0 (RADIATION), External Beam Radiation Therapy 1 (RADIATION).
Who is sponsoring clinical trial NCT05288777?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05288777 being conducted?
This trial has 1 study location across Virginia. 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 NCT05288777's enrollment target sits among peer trials
45 843rd of 1224 higher than 374 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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