Clinical trial · Observational
BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients treated with radiotherapy
- description
- 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
- interventionNames
- Radiation: Breast Radiotherapy with or without Deep Inspiration Breath Hold (DIBH)
Primary outcomes (3)
- measure
- Change in mean heart dose (Dmean, Gy) with ABC-assisted DIBH
- timeFrame
- At baseline RT planning (Day 1)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available