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NCT05592938 · ClinicalTrials.gov registry record · NA
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
A NA study of Breast Cancer and Breast Cancer Recurrent, sponsored by University Health Network, Toronto.
- Recruiting
- Registry status
- NA
- Development phase
- 171
- Enrollment target
- 15
- Study locations
NCT05592938: Recruiting NA study of Breast Cancer and Breast Cancer Recurrent, sponsored by University Health Network, Toronto.
NCT05592938 is a NA study of Breast Cancer and Breast Cancer Recurrent that is actively recruiting participants, run by University Health Network, Toronto. The registered enrollment target is 171 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05592938, a NA study of Breast Cancer and Breast Cancer Recurrent, is actively recruiting participants, sponsored by University Health Network, Toronto.
- RECRUITING
- Registry status
- NA
- Development phase
- 171 participants
- Enrollment target
- 15
- Study locations
Study Summary
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).
Primary Outcome
TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Conditions Studied
Interventions
- RADIATION rPBI
Study Locations (15)
Ontario
- Royal Victoria Regional Health Centre - Barrie
- Verspeeten Family Cancer Centre - London
- Odette Cancer Centre - Toronto
- Princess Margaret Cancer Centre - Toronto
Quebec
- CHU de Québec-Université Laval - Montreal
- Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal - Montreal
- Centre hospitalier de l'Université de Montréal - Montreal
New York
- NYU Langone Health - New York
- Columbia University Medical Center - New York
Other
- Tel-Aviv Sourasky Medical Centre - Tel Aviv
- Florence University Hospital - Florence
Virginia
- Virgina Community University Massey Comprehensive Cancer Center - Richmond
Victoria
- Peter MacCallum Cancer Centre - Melbourne
São Paulo
- A.C.Camargo Cancer Center - São Paulo
Jordan
- King Hussein Cancer Centre - Amman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2027-06-27 |
| Phase | NA |
What NCT05592938 shows while recruiting
NCT05592938 is an interventional study that assigns participants to a tested intervention. The registered 171 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 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which rPBI is the first listed.
NCT05592938 lists 15 locations in 8 states (Ontario, Quebec, New York).
Frequently Asked Questions
What is clinical trial NCT05592938 about?
NCT05592938 is a clinical study titled "Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)". Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with le...
What is the current status of trial NCT05592938?
This trial is currently recruiting. It is a NA study. The enrollment target is 171 participants. The study started on 2023-06-27. Estimated completion is 2027-06-27.
What conditions does trial NCT05592938 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Cancer Recurrent.
What interventions are being tested in trial NCT05592938?
The interventions under investigation include: rPBI (RADIATION).
Who is sponsoring clinical trial NCT05592938?
This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05592938 being conducted?
This trial has 15 study locations across New York, Virginia, Victoria, São Paulo, Ontario. 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 NCT05592938's enrollment target sits among peer trials
171 420th of 1224 higher than 805 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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