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

NCT06611306 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

DE-iPTV

Dose-escalated VMAT-based radiotherapy, as previously described in our planning study

Sponsors & Collaborators

  • University of Leicester

    collaborator OTHER

  • Centro Nacional de Investigaciones Oncologicas CARLOS III

    collaborator OTHER

  • East and North Hertfordshire NHS Trust

    collaborator OTHER_GOV

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611306 on ClinicalTrials.gov