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 range18 Years

SexALL

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)

What they're measuring

Change in mean heart dose (Dmean, Gy) with ABC-assisted DIBH

Timeframe: At baseline RT planning (Day 1)

Change in mean dose (Dmean, Gy) to cardiac substructures with ABC-assisted DIBH

Timeframe: At baseline RT planning (Day 1)

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Elisabetta Bonzano, MD, PhD

+39 0382503133 e.bonzano@smatteo.pv.it

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in mean heart dose (Dmean, Gy) with ABC-assisted DIBH

Timeframe: At baseline RT planning (Day 1)

Change in mean dose (Dmean, Gy) to cardiac substructures with ABC-assisted DIBH

Timeframe: At baseline RT planning (Day 1)

Change in maximum dose (Dmax, Gy) to cardiac substructures with ABC-assisted DIBH

Timeframe: At baseline RT planning (Day 1)