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Trial Title:
BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
NCT ID:
NCT06611306
Condition:
Brain Metastases, Adult
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Conditions: Keywords:
Radiotherapy
Brain metastases
Metastatic Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Non-randomised interventional multi-centre feasibility trial in patients with brain
metastases from breast cancer receiving dose escalated internal PTV (DE-iPTV)
radiotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
DE-iPTV
Description:
Dose-escalated VMAT-based radiotherapy, as previously described in our planning study
Arm group label:
DE-iPTV radiotherapy
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.
Detailed description:
Brain metastases from breast cancer are a common, and devastating, complication with
survival times of 3 - 5 months from diagnosis.
The main treatment approaches to brain metastases are surgery, stereotactic radiosurgery
(SRS), and whole brain radiotherapy. However, it is known that most patients with brain
metastases receive either whole-brain radiotherapy (WBRT) or no treatment, with
relatively low rates of surgery and SRS. Since the commonest treatment in those who do
have treatment is WBRT, the local team have developed an approach that is believed to be
(possibly) more effective than WBRT. The objective is to evaluate this approach in
patients who are not suitable to receive more aggressive treatment and who would
otherwise receive WBRT. The local approach involves using a modern radiotherapy planning
approach, combined with careful, intra-metastasis dose escalation (Dose Escalated
internal PTV (DE-iPTV)) to deliver a higher dose to tumour, while delivering less dose to
the brain. The combination of less dose to normal structures and more dose to the lesion
will hopefully improve Health-related Quality of Life (HRQoL).
The aim of this study is to demonstrate the feasibility of delivering complex
radiotherapy, dose escalated internal PTV (DE-iPTV), and measuring quality of life at 8
weeks post-enrolment for patients with brain metastases from breast cancer who would
otherwise receive WBRT. An exploratory blood-based biomarker sample collection and
analysis will be completed. Furthermore, linked national cancer data will be used to
measure the number of patients currently offered WBRT, including survival costs and
hospital admissions, and thus provide a baseline to estimate the impact of this novel
approach.
Criteria for eligibility:
Criteria:
Inclusion Criteria
1. Written (signed and dated) informed consent and be capable of co-operating with
treatment and follow-up
2. Adult (aged 16+) patients, resident in the United Kingdom.
3. Histologically confirmed primary breast cancer with brain metastases on MRI imaging
4. The treating oncologist considers whole-brain radiotherapy to be the most suitable
treatment outside of the trial.
5. Eastern Cooperative Oncology Group Performance status 0, 1 or 2
6. Able to respond to question about their quality of life, symptoms, and side effects
remotely (via telephone assessments
7. Life expectancy from extra-cranial disease >3 months
Exclusion Criteria
1. Leptomeningeal disease
2. "Miliary" pattern of metastases: patients with over 15 metastases are excluded
(clinician-based assessment)
3. Cystic metastases
4. Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)
5. Plan for hippocampal-sparing whole brain radiotherapy.
6. Unable to give informed consent.
7. Prognosis less than 3 months
8. Pregnant or nursing women
9. Unable to complete a brain MRI and/or known allergy to gadolinium.
Gender:
All
Minimum age:
16 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Imperial College London
Address:
City:
London
Zip:
SW7 2AZ
Country:
United Kingdom
Contact:
Last name:
Lillie Pakzad Shahabi, BSc MSc
Email:
beat-breast@imperial.ac.uk
Contact backup:
Last name:
Matt Williams, FRCR PhD
Phone:
02033118427
Email:
matthew.williams@imperial.ac.uk
Start date:
January 6, 2025
Completion date:
December 2026
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
University of Leicester
Agency class:
Other
Collaborator:
Agency:
Centro Nacional de Investigaciones Oncologicas CARLOS III
Agency class:
Other
Collaborator:
Agency:
East and North Hertfordshire NHS Trust
Agency class:
Other
Collaborator:
Agency:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Imperial College Healthcare NHS Trust
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611306
https://www.computationaloncology.net/aroma
