Recruiting

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

ClinicalTrials.gov IDNCT06611306

PhaseNA

Enrollment42

SponsorImperial College London

Age16 Years – 100 Years

SexALL

I'm interested View official listing

Conditions studied

Brain Metastases, Adult, Breast Cancer

About this study

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

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

Primary outcomes

Feasibility of delivering DE-iPTV and measuring health related quality of life questionnaire in patients with brain metastases from breast cancer to whom their treating clinician would normally offer whole brain radiotherapy (8 weeks post-enrolment)

Eligibility information

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.

Study locations

Imperial College London, London, London SW7 2AZ United Kingdom
University of Oxford Cancer and Haematology Centre | Churchill Hospital Headington, Oxford,, Oxford, OX3 7LE United Kingdom

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.