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

Sponsor: Imperial College London • ClinicalTrials.gov ID: NCT06611306

Registry updated: 2026-10-08

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Description

The aim of this study is to demonstrate if it is possible to delivering a novel and modern radiotherapy approach (Dose Escalated internal PTV (DE-iPTV)) and to collect health related quality of life in patients whose breast cancer has spread to the brain (brain metastases) at 8 weeks post enrolling into the study. The main questions that have been set out to to answer are: * Is it possible to deliver the novel radiotherapy approach, DE-iPTV? * Is it possible to measure health -related quality of life? * What impact does the novel radiotherapy approach have on: patient's quality of life, control of the brain metastasis (control of the lesion) and steroid use? Participants will: * Receive 5 doses of radiotherapy * Complete weekly quality of life (EQ-5D) assessments and medication (steroid) diaries (via telephone/ postal) until 12 weeks post enrolment * Be reviewed in clinic with up-to-date MRI scans at 8, 12 and 24 weeks post-enrolment * Complete a more detailed HRQoL panel of assessments will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks post enrolment.

Interventions

DE-iPTV (Radiation)
Dose-escalated VMAT-based radiotherapy, as previously described in our planning study

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.

Conditions

Brain Metastases, Adult Breast Cancer

Locations

Imperial College London — London, London, United Kingdom
University of Oxford Cancer and Haematology Centre | Churchill Hospital Headington, Oxford, — Oxford, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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