RecruitingNCT07299812

BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

400 participants

Start Date

May 23, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Radiotherapy

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). 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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)

Interventions

RADIATIONBreast 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.