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NCT03422003 · ClinicalTrials.gov registry record · NA
Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
A NA study of Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 15
- Study locations
NCT03422003: Active NA study of Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT03422003 is a NA study of Breast Cancer that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 400 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03422003, a NA study of Breast Cancer, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.
Primary Outcome
The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being (PWB) sub-domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. The FACT-B is a 37-item instrument designed to measure five domains of health-related quality of life in breast cancer patients. The higher the score, the better the quality of life. Score ranges: * The score range for the FACT-B total score is 0-148. * The score range for the PWB, social/
Conditions Studied
Interventions
- RADIATION Radiation Therapy
Study Locations (15)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
- Massachusetts General Hospital/North Shore Center for Outpatient Care - Danvers
- Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center - Milford
- Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital - South Weymouth
California
- University of California, San Francisco - San Francisco
- Stanford University Medical Center - Stanford
Maine
- Eastern Maine Medical Center - Brewer
- Maine Medical Center - Scarborough
Colorado
- Vail Health - Edwards
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Johns Hopkins Medicine - Washington D.C.
Rhode Island
- Lifespan/Rhode Island Hospital - Providence
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2030-04-01 |
| Phase | NA |
What the registry record for NCT03422003 still lists
NCT03422003 is an interventional study that assigns participants to a tested intervention. The registered 400 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 (86% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Radiation Therapy is the first listed.
NCT03422003 lists 15 locations in 8 states (Massachusetts, California, Maine).
Frequently Asked Questions
What is clinical trial NCT03422003 about?
NCT03422003 is a clinical study titled "Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma". This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side...
What is the current status of trial NCT03422003?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2018-04-01. Estimated completion is 2030-04-01.
What conditions does trial NCT03422003 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03422003?
The interventions under investigation include: Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03422003?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03422003 being conducted?
This trial has 15 study locations across California, Colorado, Connecticut, District of Columbia, Maine. 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 NCT03422003's enrollment target sits among peer trials
400 233rd of 1224 higher than 981 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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