Breast radiotherapy using active breath hold to reduce heart exposure
BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
This project will see if using an Active Breathing Coordinator (ABC) for deep inspiration breath hold reduces radiation dose to the heart in adults with stage I–III breast cancer receiving radiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07299812 on ClinicalTrials.gov |
What this trial studies
BRAVE-HEART is an ambispective, observational single-center study at Fondazione IRCCS Policlinico San Matteo that documents cardiac dose reduction when radiotherapy is delivered with ABC‑assisted deep inspiration breath hold (DIBH). Dosimetric parameters from patients treated with DIBH are compared against free‑breathing plans and historical free‑breathing patients to quantify reductions to the heart and substructures such as the left anterior descending artery. The study enrolls adults with stage I–III breast carcinoma treated with 3D‑CRT or IMRT/VMAT using conventional, hypofractionated, or ultrahypofractionated schedules, with or without a simultaneous integrated boost. Secondary analyses examine treatment reproducibility, differences between techniques and fractionation, the impact of SIB, and acute and late toxicity during follow-up.
Who should consider this trial
Good fit: Adults (≥18 years) with stage I–III breast cancer who are scheduled for postoperative or definitive radiotherapy and who can cooperate with ABC‑assisted DIBH (or are treated under free‑breathing if DIBH is not feasible) are ideal candidates.
Not a fit: Patients with severe respiratory or cardiovascular disease who cannot perform or maintain breath‑hold maneuvers, pregnant patients, or those with absolute contraindications to radiotherapy are unlikely to benefit from ABC‑assisted DIBH.
Why it matters
Potential benefit: If successful, the approach could lower radiation exposure to the heart and coronary arteries and reduce long-term cardiac complications after breast radiotherapy.
How similar studies have performed: Multiple prior studies have shown that DIBH techniques can reduce cardiac dose in left‑sided breast radiotherapy, so the approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Elisabetta Bonzano, MD, PhD
- Email: e.bonzano@smatteo.pv.it
- Phone: +39 0382503133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.