Clinical Trial

BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART

Study acronym: BRAVE-HEART
Recruiting
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Record status
This record was last updated December 23, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
The BRAVE-HEART trial is an ambispective, observational, non-randomized study conducted at Fondazione IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Policlinico San Matteo (Pavia, Italy). It aims to document and quantify the cardiac dose reduction achievable with breast radiotherapy performed in Deep Inspiration Breath Hold (DIBH) using the Active Breathing Coordinator (ABC) system. Dosimetric parameters from DIBH treatments are evaluated, with free-breathing treatment plans and data from patients treated under free-breathing conditions used as reference. Secondary analyses include treatment reproducibility, comparison of radiotherapy techniques and fractionation schedules, impact of the simultaneous integrated boost (SIB), and assessment of acute and late toxicity during follow-up.
Trial Details
NCT Number NCT07299812
Lead Sponsor Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions Breast Cancer, Radiotherapy
Enrollment 400 participants
Start Date 2024-05-23
Primary Completion 2026-04 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2025-12-23