BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of H… (NCT07299812) | Clinical Trial Compass
RecruitingNot Applicable
BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
Italy400 participantsStarted 2024-05-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mean heart dose (Dmean, Gy) with ABC-assisted DIBH
Timeframe: At baseline RT planning (Day 1)
2
Change in mean dose (Dmean, Gy) to cardiac substructures with ABC-assisted DIBH
Timeframe: At baseline RT planning (Day 1)
3
Change in maximum dose (Dmax, Gy) to cardiac substructures with ABC-assisted DIBH
Timeframe: At baseline RT planning (Day 1)
Trial details
NCT IDNCT07299812
SponsorFondazione IRCCS Policlinico San Matteo di Pavia