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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.

Study acronym: BEAT-Breast
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from Imperial College London

Record History

  1. Primary completion pushed from Dec 2026 to Dec 2027 Recruitment opened · Start date changed from estimate of Jan 6, 2025 to Jun 1, 2026 · Completion pushed from Dec 2026 to Jun 2028 · 4 more Show 7 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Jan 6, 2025 to Jun 1, 2026
    • Completion pushed from Dec 2026 to Jun 2028
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 12 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary endpoint revised Start date: Jan 2025 to Jan 6, 2025 · Secondary endpoints: details revised at 1 of 12 entries · Study title shortened, about 7 words · 1 morev2 Show 4 more changesShow less
    • Start date: Jan 2025 to Jan 6, 2025
    • Secondary endpoints: details revised at 1 of 12 entries
    • Study title shortened, about 7 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06611306
Lead Sponsor Imperial College London
Collaborators: University of Leicester, Centro Nacional de Investigaciones Oncologicas CARLOS III, East and North Hertfordshire NHS Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust
Conditions Brain Metastases, Adult, Breast Cancer
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov