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

NCT06611306 | Not Yet Recruiting

• 1 other identifier: C/46/2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Brain Metastases, Adult; Breast Cancer

Keywords

Radiotherapy; Brain metastases; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (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

  Completion of radiotherapy and completion of EuroQol- 5 Dimension (EQ-5D-5L) questionnaire

  8 weeks post-enrolment

Secondary Outcomes (12)

• Lesional Response

  8 weeks

• Intracranial progression

  3 months

• Intracranial progression

  6 months

• Treatments

  Within 6 months of enrolment

• Central Nervous System (CNS) Failures

  Within 6 months of enrolment

Other Outcomes (3)

• Changes in blood-based biomarkers

  8 weeks

• Imaging Changes

  Up to 6 months post enrolment

• Radiation Necrosis

  Up to 6 months post enrolment

Study Arms (1)

DE-iPTV radiotherapy

EXPERIMENTAL

Patients will undergo a radiotherapy planning scan, and an upto date MRI brain with contrast. Patients will receive 5 fractions of DE-iPTV radiotherapy over 1 week.

Radiation: DE-iPTV

Interventions

DE-iPTV RADIATION

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

DE-iPTV radiotherapy

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Plan for hippocampal-sparing whole brain radiotherapy.
• Unable to give informed consent.
• Prognosis less than 3 months
• Pregnant or nursing women
• Unable to complete a brain MRI and/or known allergy to gadolinium.

Sponsors & Collaborators

• Imperial College London: lead
• 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

Study Sites (1)

Imperial College London

London, SW7 2AZ, United Kingdom

Location

Related Publications (1)

• Chen J, Sinclair G, Rozati H, Hill L, Pakzad-Shahabi L, Wang J, Calvez KL, Paddick I, Williams M. Improving on whole-brain radiotherapy in patients with large brain metastases: A planning study to support the AROMA clinical trial. Radiother Oncol. 2022 May;170:176-183. doi: 10.1016/j.radonc.2022.02.011. Epub 2022 Feb 17.

  PMID: 35182688 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Lillie Pakzad-Shahabi, BSc MSc

CONTACT

02033118427; beat-breast@imperial.ac.uk

Matt Williams, FRCR PhD

CONTACT

02033118427; matthew.williams@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomised interventional multi-centre feasibility trial in patients with brain metastases from breast cancer receiving dose escalated internal PTV (DE-iPTV) radiotherapy

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)