Status:
NOT_YET_RECRUITING
BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
University of Leicester
Centro Nacional de Investigaciones Oncologicas CARLOS III
Conditions:
Brain Metastases, Adult
Breast Cancer
Eligibility:
All Genders
16-100 years
Phase:
NA
Brief 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 i...
Detailed Description
Brain metastases from breast cancer are a common, and devastating, complication with survival times of 3 - 5 months from diagnosis. The main treatment approaches to brain metastases are surgery, ster...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- Leptomeningeal disease
- "Miliary" pattern of metastases: patients with over 15 metastases are excluded (clinician-based assessment)
- Cystic metastases
- Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)
- Plan for hippocampal-sparing whole brain radiotherapy.
- Unable to give informed consent.
- Prognosis less than 3 months
- Pregnant or nursing women
- Unable to complete a brain MRI and/or known allergy to gadolinium.
Exclusion
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06611306
Start Date
January 6 2025
End Date
December 1 2026
Last Update
October 15 2024
Active Locations (1)
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1
Imperial College London
London, United Kingdom, SW7 2AZ