Clinical Trial

Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

Study acronym: DEBoRa
Recruiting
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Record status
This record was last updated June 15, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients. The main question\[s\] it aims to answer are: * evaluate the rate of all grades of radiation-induced fibrosis at 4 years. * evaluate poor/fair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die)
Trial Details
NCT Number NCT07021846
Lead Sponsor Fondazione Policlinico Universitario Campus Bio-Medico
Conditions Breast Cancer
Enrollment 132 participants
Start Date 2020-03-12
Primary Completion 2026-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2025-06-15