An observational study in Breast Cancer and Radiotherapy, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational
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.
The BRAVE-HEART study is an ambispective, observational, non-randomized, single-center study conducted at Fondazione IRCCS Policlinico San Matteo (Pavia, Italy). The purpose of the study is to document and quantify the heart-sparing effect of breast radiotherapy delivered with Deep Inspiration Breath Hold (DIBH) assisted by the Active Breathing Coordinator (ABC), as implemented in routine clinical practice.
The study includes patients with stage I-III breast carcinoma undergoing radiotherapy according to institutional standards, most commonly after conservative or radical surgery. Radiotherapy is delivered using three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated/volumetric modulated arc therapy (IMRT/VMAT) techniques, with conventional, hypofractionated, or ultrahypofractionated regimens, with or without a simultaneous integrated boost (SIB) to the tumor bed.
Eligibility for ABC-assisted DIBH is assessed at CT simulation. Patients unable to perform or maintain the breath-hold maneuver are treated under free-breathing conditions. Free-breathing treatment plans and data from patients treated under free-breathing conditions are used as dosimetric references to quantify the magnitude of cardiac dose reduction achievable with ABC-assisted DIBH.
The primary objective is to assess the reduction in radiation dose delivered to the heart and its substructures, particularly the left anterior descending coronary artery (LAD), when radiotherapy is performed with ABC-assisted DIBH. Secondary objectives include evaluating treatment reproducibility and the feasibility of ABC-DIBH in daily practice, comparing dosimetric parameters among different radiotherapy techniques (3D-CRT vs VMAT/IMRT), describing the impact of different fractionation schemes (conventional, hypofractionated, and ultrahypofractionated) and SIB on organs-at-risk exposure, and collecting data on acute and late toxicity during follow-up.
The study aims to provide real-world evidence on the effectiveness, reproducibility, and clinical applicability of ABC-assisted DIBH for cardiac sparing in breast cancer radiotherapy.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 400 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ambispective cohort of patients with stage I-III breast carcinoma treated with radiotherapy at Fondazione IRCCS Policlinico San Matteo. Radiotherapy may include whole or partial breast or chest wall, with or without nodal irradiation, delivered with 3D-CRT or IMRT/VMAT. The Active Breathing Coordinator (ABC) system is used for DIBH when feasible; patients unable to perform DIBH are treated under free-breathing conditions. Different fractionation schedules and SIB may be used according to clinical indications.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single ambispective observational cohort of patients with breast cancer undergoing radiotherapy according to institutional clinical practice. Within this cohort, eligible patients are treated with the Active Breathing Coordinator-assisted Deep Inspiration Breath Hold (DIBH) technique. Free-breathing treatment plans or patients treated in free-breathing conditions are used as dosimetric references to estimate the reduction in radiation doses to the heart and cardiac substructures achievable with DIBH. Assignment to DIBH or free-breathing conditions is non-randomized and based on clinical suitability and patient cooperation
Radiation: Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH)
Observational study of breast cancer patients treated with radiotherapy delivered using the Active Breathing Coordinator (ABC) system during Deep Inspiration Breath Hold (DIBH), as implemented in standard clinical practice. Free-breathing treatment plans or patients treated in free-breathing conditions are used as dosimetric references to estimate the reduction in radiation doses to the heart and cardiac substructures achievable with DIBH.
Change in mean heart dose (Dmean, Gy) with ABC-assisted DIBH
Measurement of mean heart dose (Dmean, Gy) in breast cancer patients treated with radiotherapy using ABC-assisted Deep Inspiration Breath Hold (DIBH). Dosimetric comparisons are performed using corresponding free-breathing treatment plans or data from patients treated under free-breathing conditions. All Dmean (Gy) values are derived from the dose-volume histogram (DVH) to evaluate changes in cardiac radiation exposure associated with DIBH.
Time frame: At baseline RT planning (Day 1)
Change in mean dose (Dmean, Gy) to cardiac substructures with ABC-assisted DIBH
Change in mean dose (Dmean, Gy) to predefined cardiac substructures (left anterior descending coronary artery, left ventricle) between DIBH and corresponding free-breathing plans or data from patients treated under free-breathing conditions. All Dmean (Gy) values are derived from the dose-volume histogram (DVH).
Time frame: At baseline RT planning (Day 1)
Change in maximum dose (Dmax, Gy) to cardiac substructures with ABC-assisted DIBH
Change in maximum dose (Dmax, Gy) to predefined cardiac substructures (left anterior descending coronary artery, left ventricle) between DIBH and corresponding free-breathing plans or data from patients treated under free-breathing conditions. All Dmax (Gy) values are derived from the dose-volume histogram (DVH).
Time frame: At baseline RT planning (Day 1)
Treatment setup reproducibility using ABC-DIBH
Assessment of setup accuracy in patients receiving left-sided breast cancer radiotherapy using deep inspiration breath-hold (DIBH), measured as translational setup shifts (mm) on daily verification imaging.
Time frame: At treatment completion (within 1 week of last fraction)
Dosimetric comparison between 3D conformal radiotherapy and VMAT/IMRT plans
Analysis of dose-volume histogram (DVH) parameters for target volumes and organs at risk to compare 3D-CRT and VMAT/IMRT techniques in patients treated with breast radiotherapy.
Time frame: At baseline RT planning (Day 1)
Impact of different fractionation schemes on cardiac and lung doses
Descriptive analysis of dosimetric parameters (heart Dmean, LAD Dmax/Dmean, ipsilateral lung Dmean, Gy) according to the fractionation schedule adopted (conventional, hypofractionated, and ultrahypofractionated regimens), in patients treated with radiotherapy using DIBH or free-breathing.
Time frame: At baseline RT planning (Day 1)
Radiotherapy-related toxicity (acute)
Collection and grading of acute toxicity during radiotherapy according to institutional or CTCAE criteria, in patients treated with DIBH or free-breathing.
Time frame: 90 days after radiotherapy
Radiotherapy-related toxicity (late)
Collection and grading of late toxicity during follow-up, according to institutional or CTCAE criteria, in patients treated with DIBH or free-breathing.
Time frame: 12-month follow-up
Identification of dosimetric cut-offs for cardiac sparing
Exploratory analysis to identify candidate dose (Gy) thresholds for the heart and left anterior descending coronary artery (LAD), based on the distribution of dose-volume histogram (DVH) parameters within the study cohort. These exploratory dosimetric cut-offs will be considered as potential reference values for cardiac sparing in future studies.
Time frame: At baseline RT planning (Day 1)
Change in dosimetric parameters with the use of a simultaneous integrated boost (SIB)
Assessment of changes in predefined dosimetric parameters associated with the use of a simultaneous integrated boost (SIB) in breast radiotherapy delivered according to institutional clinical practice, including treatments performed with ABC-assisted Deep Inspiration Breath Hold (DIBH) or under free-breathing conditions. The analysis includes target coverage metrics (PTV) and organ-at-risk dose metrics (heart and lung; Gy). Comparisons are performed between treatment plans generated with and without SIB within the study cohort. All values are derived from the dose-volume histogram (DVH).
Time frame: At baseline RT planning (Day 1)
Started May 2024 (actual). Primary completion is estimated for Apr 2026, 23 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 23 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
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