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BEAT-Breast - Improving Outcomes for Breast Cancer Patients With Brain Metastases: a Pilot Nonrandomised Single Arm Phase 2 Clinical Trial in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 100
Healthy Volunteers: f
View:

• Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up

• Adult (aged 16+) patients, resident in the United Kingdom.

• Histologically confirmed primary breast cancer with brain metastases on MRI imaging

• The treating oncologist considers whole-brain radiotherapy to be the most suitable treatment outside of the trial.

• Eastern Cooperative Oncology Group Performance status 0, 1 or 2

• Able to respond to question about their quality of life, symptoms, and side effects remotely (via telephone assessments

• Life expectancy from extra-cranial disease \>3 months

Locations
Other Locations
United Kingdom
Imperial College London
RECRUITING
London
University of Oxford Cancer and Haematology Centre | Churchill Hospital Headington, Oxford,
RECRUITING
Oxford
Contact Information
Primary
Lillie Pakzad-Shahabi, BSc MSc
beat-breast@imperial.ac.uk
02033118427
Backup
Matt Williams, FRCR PhD
matthew.williams@imperial.ac.uk
02033118427
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 42
Treatments
Experimental: DE-iPTV radiotherapy
Patients will undergo a radiotherapy planning scan, and an upto date MRI brain with contrast. Patients will receive 5 fractions of DE-iPTV radiotherapy over 1 week.
Related Therapeutic Areas
Sponsors
Collaborators: University of Leicester, Norfolk and Norwich University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, East and North Hertfordshire NHS Trust, Centro Nacional de Investigaciones Oncologicas CARLOS III
Leads: Imperial College London

This content was sourced from clinicaltrials.gov