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NCT02453737 · ClinicalTrials.gov registry record · Phase 2
A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca
A Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
- 3
- Study locations
NCT02453737: Completed Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.
NCT02453737 is a Phase 2 study of Breast Cancer that has completed, run by Mayo Clinic. The registered enrollment target is 170 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02453737, a Phase 2 study of Breast Cancer, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.
Primary Outcome
Participants end up being rated as fair or poor cosmesis from baseline. Excellent: treated breast nearly identical to untreated breast Good: treated breast slightly different than untreated (minimal but identifiable effects of the treated breast) Fair: Treated breast clearly different from untreated but not seriously distorted (significant radiation effects readily observable) Poor: Treated breast seriously distorted (severe sequelae of breast tissue secondary to radiation effects)
Conditions Studied
Interventions
- RADIATION Brachytherapy APBI
- RADIATION 3D-CRT (photon) APBI
- RADIATION Proton APBI
Study Locations (3)
Arizona
- Mayo Clinic - Phoenix
Florida
- Mayo Clinic - Jacksonville
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2015-06-16 |
| Est. Completion | 2022-09-21 |
| Phase | Phase 2 |
What the finished NCT02453737 record still lists
NCT02453737 is an interventional study that assigns participants to a tested intervention. The registered 170 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 (94% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Brachytherapy APBI is the first listed.
NCT02453737 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02453737 about?
NCT02453737 is a clinical study titled "A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca". This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery o...
What is the current status of trial NCT02453737?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2015-06-16. Estimated completion is 2022-09-21.
What conditions does trial NCT02453737 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02453737?
The interventions under investigation include: Brachytherapy APBI (RADIATION), 3D-CRT (photon) APBI (RADIATION), Proton APBI (RADIATION).
Who is sponsoring clinical trial NCT02453737?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02453737 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02453737's enrollment target sits among peer trials
170 421st of 1224 higher than 802 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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