Actively Recruiting
BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-12-23
400
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage I-III breast carcinoma with an indication for radiotherapy
- Invasive carcinoma or ductal carcinoma in situ (DCIS)
- Radiotherapy delivered using three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated/volumetric modulated arc therapy (IMRT/VMAT) techniques
- Ability to actively cooperate in using the Active Breathing Coordinator (ABC) system for Deep Inspiration Breath Hold (DIBH), or treated under free-breathing conditions when DIBH is not feasible
- Age 18 years
- Ability to provide written informed consent for the anonymous use of data for research purposes
You will not qualify if you...
- Severe health problems or profound hearing loss
- Severe respiratory or cardiovascular conditions in the medical history that contraindicate radiotherapy
- Inability to provide written informed consent for the anonymous use of data for research purposes
- Absolute contraindications to radiotherapy (e.g., pregnancy, or inability to maintain the correct treatment position)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
E
Elisabetta Bonzano, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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