BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-100
SponsorImperial College London

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • DE-iPTV

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators

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