BEAT-Breast
Research type
Research Study
Full title
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.
IRAS ID
328590
Contact name
Matt Williams
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
Brain metastases (cancer that has spread from a different part of the body to the brain) from breast cancer are a common, yet devastating, complication with survival times of 3 - 5 months from diagnosis. Currently treatment in this group of patients include surgery, stereotactic radiosurgery (SRS), and whole brain radiotherapy (WBRT). However, most patients will either receive WBRT or no treatment and the number of patients who receive surgery and SRS are lower. As the commonest treatment for patients with brain metastasis, which are not treatable with surgery or SRS, is WBRT, we have developed an approach to improve what we think may be more effective. Our approach, dose escalated internal PTV (DE-iPTV)), delivers a higher dose of radiotherapy to the tumour, while delivering less dose to the “normal” brain. We hope that our approach would improve Health-related Quality of Life (HRQoL) by resulting in less side effects.
Through the BEAT-Breast trial we set out to demonstrate the feasibility of DE-iPTV in this group of patients as well as if it is possible to measure their quality of life 8 weeks following their enrolment into the trial.
Alongside this clinical trial, we will work with the Imperial College London Computational Oncology lab to access the NHS England Trusted Research Environment (TRE) through DATACAN. Using linked national cancer data, we can measure the number of patients currently offered WBRT, including survival costs and hospital admissions. In addition, we will collect data on recent historical and contemporary controls in the form of patients undergoing WBRT in the trial centres. That data will be collected locally, pseudonymised and then shared centrally so that we can estimate the outcomes in a contemporaneous patients treated with WBRT from the same centres as are recruiting trial patients.
REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0054
Date of REC Opinion
25 Feb 2025
REC opinion
Further Information Favourable Opinion