NCT06611306Recruiting
BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 23 Sept 2024
- Start date
- 1 Jun 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Imperial College London
- NCT number
- NCT06611306
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 1 Jun 2026 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)
- Plan for hippocampal-sparing whole brain radiotherapy.
Other illness
- Leptomeningeal disease
- Unable to complete a brain MRI and/or known allergy to gadolinium.
Other
- "Miliary" pattern of metastases: patients with over 15 metastases are excluded (clinician-based assessment)
- Cystic metastases
- Unable to give informed consent.
- Prognosis less than 3 months
- Pregnant or nursing women
Who the study is looking for
- 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
Age in the registry: 16 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University of Oxford Cancer and Haematology Centre | Churchill Hospital Headington, Oxford, Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.