Breast CancerBRAVE-HEARTNCT07299812
BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
An observational study of Breast Cancer and Radiotherapy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Radiotherapy
- What is being tested?
- Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH)
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2024to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Elisabetta Bonzano, MD, PhD, e.bonzano@smatteo.pv.it
Elisabetta Bonzano, MD, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Radiotherapy
- Being tested
- Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH)
- Keywords
- Breast cancer, Radiation therapy, Deep inspiration breath hold (DIBH), Cardiac dose, Heart sparing, Active Breathing Coordinator (ABC), Dosimetric analysis, Elderly breast cancer, Simultaneous Integrated Boost (SIB), Hypofractionated radiotherapy, Ultrahypofractionated radiotherapy, Conventional fractionation, Three-dimensional conformal radiotherapy (3D-CRT), Intensity-modulated radiotherapy (IMRT), Volumetric modulated arc therapy (VMAT), Cardiotoxicity, Breast radiotherapy
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH)Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients treated with radiotherapy | 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 Receives: Radiation: Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: At baseline RT planning (Day 1)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At baseline RT planning (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start23 May 2024
- Primary completionApr 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabetta Bonzano, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299812
- Sponsor's protocol ID
- BRAVE-HEART
- Acronym
- BRAVE-HEART
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
- ClinicalTrials.gov ID
- NCT07299812
- Acronym / sponsor ID
- BRAVE-HEART / BRAVE-HEART
- Conditions
- Breast Cancer, Radiotherapy
- Keywords
- Breast cancer, Radiation therapy, Deep inspiration breath hold (DIBH), Cardiac dose, Heart sparing, Active Breathing Coordinator (ABC), Dosimetric analysis, Elderly breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients treated with radiotherapy | – | Radiation: Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Breast cancer patients treated with radiotherapy |
Primary outcome
Change in mean heart dose (Dmean, Gy) with ABC-assisted DIBH
Time frame: At baseline RT planning (Day 1)
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.
Change in mean dose (Dmean, Gy) to cardiac substructures with ABC-assisted DIBH
Time frame: At baseline RT planning (Day 1)
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).
Change in maximum dose (Dmax, Gy) to cardiac substructures with ABC-assisted DIBH
Time frame: At baseline RT planning (Day 1)
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).
7 secondary outcomes
Treatment setup reproducibility using ABC-DIBH
Time frame: At treatment completion (within 1 week of last fraction)
Dosimetric comparison between 3D conformal radiotherapy and VMAT/IMRT plans
Time frame: At baseline RT planning (Day 1)
Impact of different fractionation schemes on cardiac and lung doses
Time frame: At baseline RT planning (Day 1)
Radiotherapy-related toxicity (acute)
Time frame: 90 days after radiotherapy
Radiotherapy-related toxicity (late)
Time frame: 12-month follow-up
Identification of dosimetric cut-offs for cardiac sparing
Time frame: At baseline RT planning (Day 1)
Change in dosimetric parameters with the use of a simultaneous integrated boost (SIB)
Time frame: At baseline RT planning (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiotherapy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabetta Bonzano, MD, PhD (+39 0382503133, e.bonzano@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean heart dose (Dmean, Gy) with ABC-assisted DIBH (time frame: At baseline RT planning (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.