BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
NCT ID: NCT07299812
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-05-23
2028-11-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Elisabetta Bonzano
Principal Investigator
Locations
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Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Countries
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Central Contacts
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Facility Contacts
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Elisabetta Bonzano, MD, PhD
Role: primary
Other Identifiers
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BRAVE-HEART
Identifier Type: -
Identifier Source: org_study_id