Breast radiotherapy using active breath hold to reduce heart exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Level I–II axillary radiation versus whole regional nodal radiation after surgery for breast cancer with 1–2 sentinel-node macrometastases.

  This will test whether limiting radiation to level I–II axillary lymph nodes works as well as whole regional nodal radiation for women with early breast cancer and 1–2 sentinel-node macrometastases.

  Recruiting Fudan University · Guiyang, Guizhou and 14 other locations · NCT07469267

• Radiation with new targeted and immune drugs for metastatic breast cancer

  This project will see how well radiation is tolerated when given at the same time as newer systemic drugs (targeted therapies, antibody‑drug conjugates, TKIs, or immunotherapy) in people with stage IV breast cancer.

  Recruiting Fondazione Policlinico Universitario Campus Bio-Medico · Rome, Italy · NCT07021911

• Using radiation therapy before chemotherapy for Luminal B breast cancer

  This study is testing if giving radiation therapy before chemotherapy can help women with Luminal B breast cancer have better results before surgery.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT05673304

• Postoperative radiotherapy options for breast cancer patients

  This study is testing different types of radiation therapy after breast cancer surgery to see which helps patients live longer without their cancer coming back.

  Recruiting Phase 3 Seoul National University Hospital · Seoul, Jongro-gu · NCT05440149

• Analysis of outcomes and side effects in patients receiving radiation therapy

  This study looks at the results and side effects of radiation therapy in patients at Winterthur Cantonal Hospital to see how treatment can be improved for future patients.

  Recruiting Kantonsspital Winterthur KSW · Winterthur, Canton of Zurich · NCT05192876

• Comparing two types of radiation therapy for breast cancer patients

  This study is testing which type of radiation therapy works better for breast cancer patients with positive lymph nodes to help them stay cancer-free after surgery.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT05059379

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.