BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Ar… (NCT06611306) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
United Kingdom42 participantsStarted 2025-01-06
Plain-language 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 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.
Who can participate
Age range16 Years – 100 Years
SexALL
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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)
What they're measuring
1
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