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.
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.
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)
Single group
DE-iPTV
RadiationDose-escalated VMAT-based radiotherapy, as previously described in our planning study
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
Completion of radiotherapy and completion of EuroQol- 5 Dimension (EQ-5D-5L) questionnaire
Lesional Response
Lesional response and intracranial progression measured using RANO-BM criteria
Intracranial progression
Intracranial progression based on RANO-BM
Intracranial progression
Intracranial progression based on RANO-BM
Treatments
Use of further brain-directed therapies (reported by clinician)
Changes in blood-based biomarkers
Change between baseline and week 8 levels of Circulating Tumour DNA (ctDNA) and S100
Imaging Changes
MRI-based response (as per RANO-BM and serial volumetric measurements)
Radiation Necrosis
Radiation necrosis based on radiologist report
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Imperial College London
Lead sponsor
University of Leicester
Collaborator
Centro Nacional de Investigaciones Oncologicas CARLOS III
Collaborator
East and North Hertfordshire NHS Trust
Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
Imperial College Healthcare NHS Trust
Collaborator
