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NCT05591547 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen
A Phase 2 study of Breast Cancer, sponsored by Sanford Health.
- Active
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 2
- Study locations
NCT05591547: Active Phase 2 study of Breast Cancer, sponsored by Sanford Health.
NCT05591547 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Sanford Health. The registered enrollment target is 91 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05591547, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Sanford Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.
Primary Outcome
To evaluate the incidence of physician-assessed adverse breast cosmesis by utilizing the Harvard Breast Cosmesis survey. The survey scores breast cosmesis from 1 to 4, with 1 representing "excellent" cosmesis, 2 representing "good" cosmesis, 3 representing "fair" cosmesis, and 4 representing "poor" cosmesis. Adverse breast cosmesis is defined as a score of either 3 or 4 on the Harvard Breast Cosmesis survey.
Conditions Studied
Interventions
- RADIATION IMRT/VMAT-Based Accelerated Partial Breast Irradiation
Study Locations (2)
Minnesota
- Sanford Health - Worthington
South Dakota
- Sanford Health - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What the registry record for NCT05591547 still lists
NCT05591547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which IMRT/VMAT-Based Accelerated Partial Breast Irradiation is the first listed.
NCT05591547 reports a single indexed study location in Minnesota, South Dakota.
Frequently Asked Questions
What is clinical trial NCT05591547 about?
NCT05591547 is a clinical study titled "Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen". This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day...
What is the current status of trial NCT05591547?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2022-03-30. Estimated completion is 2027-06.
What conditions does trial NCT05591547 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05591547?
The interventions under investigation include: IMRT/VMAT-Based Accelerated Partial Breast Irradiation (RADIATION).
Who is sponsoring clinical trial NCT05591547?
This trial is sponsored by Sanford Health, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05591547 being conducted?
This trial has 2 study locations across Minnesota, South Dakota. 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 NCT05591547's enrollment target sits among peer trials
91 612th of 1224 higher than 613 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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