BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.

Launched by IMPERIAL COLLEGE LONDON · Sep 23, 2024

Keywords

ClinConnect Summary

The BEAT-Breast trial is studying a new way to deliver radiotherapy for patients with breast cancer that has spread to the brain (called brain metastases) and who cannot receive traditional stereotactic radiotherapy. The goal is to see if this new treatment, known as Dose Escalated internal PTV (DE-iPTV), is effective and to understand how it affects patients' quality of life after 8 weeks of treatment. Researchers want to answer key questions about how well this treatment works, how it impacts daily life, and whether it reduces the need for steroids to manage symptoms.

To participate in this trial, you need to be at least 16 years old, living in the UK, and have confirmed breast cancer that has spread to the brain. You should also be able to answer questions about your health and quality of life. Participants will receive five doses of radiotherapy, and will regularly complete surveys about their well-being and medication use. Additionally, they will have follow-up appointments and MRI scans to monitor their progress over 24 weeks. It's important to note that not everyone with brain metastases will qualify for this trial, especially if there are certain complications or previous treatments involved.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
• • 2. Adult (aged 16+) patients, resident in the United Kingdom.
• • 3. Histologically confirmed primary breast cancer with brain metastases on MRI imaging
• • 4. The treating oncologist considers whole-brain radiotherapy to be the most suitable treatment outside of the trial.
• • 5. Eastern Cooperative Oncology Group Performance status 0, 1 or 2
• • 6. Able to respond to question about their quality of life, symptoms, and side effects remotely (via telephone assessments
• • 7. Life expectancy from extra-cranial disease \>3 months
• • Exclusion Criteria
• • 1. Leptomeningeal disease
• • 2. "Miliary" pattern of metastases: patients with over 15 metastases are excluded (clinician-based assessment)
• • 3. Cystic metastases
• • 4. Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)
• • 5. Plan for hippocampal-sparing whole brain radiotherapy.
• • 6. Unable to give informed consent.
• • 7. Prognosis less than 3 months
• • 8. Pregnant or nursing women
• • 9. Unable to complete a brain MRI and/or known allergy to gadolinium.