Brain Metastases, AdultBEAT-BreastNCT06611306
BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
A study testing DE-iPTV in people with Brain Metastases, Adult and Breast Cancer, run by Imperial College London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Brain Metastases, Adult, Breast Cancer
- What is being tested?
- DE-iPTV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Prognosis less than 3 months
- Pregnant or nursing women
- Unable to complete a brain MRI and/or known allergy to gadolinium.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Imperial College London
London, London, SW7 2AZ
Lillie Pakzad Shahabi, BSc MSc, beat-breast@imperial.ac.uk
Matt Williams, FRCR PhD, 02033118427, matthew.williams@imperial.ac.uk
- Recruiting
University of Oxford Cancer and Haematology Centre | Churchill Hospital Headington, Oxford,
Oxford, OX3 7LE
Oxford Cancer Trials, +441865617050, trialadministrator04@oncology.ox.ac.uk
Emma Dr Kenny-Herbert
About this study
Official title: BEAT-Breast - Improving Outcomes for Breast Cancer Patients With Brain Metastases: a Pilot Nonrandomised Single Arm Phase 2 Clinical Trial in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy
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:
Read more
- 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.
Read the 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.
- Conditions
- Brain Metastases, Adult, Breast Cancer
- Being tested
- DE-iPTV
- Keywords
- Radiotherapy, Brain metastases, Metastatic Breast Cancer
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-iPTVRadiation
Dose-escalated VMAT-based radiotherapy, as previously described in our planning study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: DE-iPTV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks post-enrolment
Secondary outcomes (12)
Lesional Response
Lesional response and intracranial progression measured using RANO-BM criteria
Measured: 8 weeks
Intracranial progression
Intracranial progression based on RANO-BM
Measured: 3 months
Intracranial progression
Intracranial progression based on RANO-BM
Measured: 6 months
Treatments
Use of further brain-directed therapies (reported by clinician)
Measured: Within 6 months of enrolment
Central Nervous System (CNS) Failures
Time to CNS failure (either lesional progression or developing a new lesion as per RANO-BM)
Measured: Within 6 months of enrolment
Neurological toxicities
Acute and late neurological/ CNS toxicity as assessed using CTCAE v5
Measured: Within 6 months of enrolment
Health Related Quality of Life
HRQoL over time (participants reported outcomes for descriptive analysis)
Measured: Within 6 months of enrolment
Time to deterioration in quality of life
Time to deterioration in Health Related Quality of Life - measured as time to first time there is a minimum clinically significant change in EuroQol- 5 Dimension (EQ-5D-5L)
Measured: Within 6 months of enrolment
Symptom Burden
Symptom burden assessed by collection of clinician-recorded toxicities
Measured: Within 6 months of enrolment
Steroid usage
Use of corticosteroids over time, assessed through clinician reports and patient diaries
Measured: Within 6 months of enrolment
Quality-Adjusted Life Year
Quality-Adjusted Life Year
Measured: Within 6 months of enrolment
Overall survival
Overall survival
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611306
- Sponsor's protocol ID
- C/46/2023
- Acronym
- BEAT-Breast
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35182688
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEAT-Breast - Improving Outcomes for Breast Cancer Patients With Brain Metastases: a Pilot Nonrandomised Single Arm Phase 2 Clinical Trial in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy
- ClinicalTrials.gov ID
- NCT06611306
- Acronym / sponsor ID
- BEAT-Breast / C/46/2023
- Conditions
- Brain Metastases, Adult, Breast Cancer
- Keywords
- Radiotherapy, Brain metastases, Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- 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
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| DE-iPTV radiotherapy | Experimental | Radiation: DE-iPTVPatients 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. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DE-iPTVDose-escalated VMAT-based radiotherapy, as previously described in our planning study | Radiation | DE-iPTV radiotherapy |
Primary outcome
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
Time frame: 8 weeks post-enrolment
Completion of radiotherapy and completion of EuroQol- 5 Dimension (EQ-5D-5L) questionnaire
12 secondary outcomes
Lesional Response
Time frame: 8 weeks
Intracranial progression
Time frame: 3 months
Intracranial progression
Time frame: 6 months
Treatments
Time frame: Within 6 months of enrolment
Central Nervous System (CNS) Failures
Time frame: Within 6 months of enrolment
Neurological toxicities
Time frame: Within 6 months of enrolment
Health Related Quality of Life
Time frame: Within 6 months of enrolment
Time to deterioration in quality of life
Time frame: Within 6 months of enrolment
Symptom Burden
Time frame: Within 6 months of enrolment
Steroid usage
Time frame: Within 6 months of enrolment
Quality-Adjusted Life Year
Time frame: Within 6 months of enrolment
Overall survival
Time frame: End of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 35182688Chen 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DE-iPTV in people with Brain Metastases, Adult and Breast Cancer, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lillie Pakzad-Shahabi, BSc MSc (02033118427, beat-breast@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 8 weeks post-enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.