CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 400 enrolled
Drug / intervention
Radiation Therapyradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03422003
NCT03422003N/AActive
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Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

Dana-Farber Cancer Institute·interventional·Posted Feb 5, 2018·Updated Nov 1, 2024

In Brief

A clinical study evaluating Radiation Therapy for Breast Cancer. Active but no longer recruiting, targeting 400 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute

Timeline

N/AActive
2018201920202021202220232024202520262027202820292030
First PostedFeb 5, 2018
Enrollment StartApr 1, 2018
Primary CompletionOct 31, 2023
Study CompletionApr 1, 2030
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 8.4 years ago

Interventions

Radiation Therapyradiation

For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes. For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.