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

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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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06611306
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Imperial College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Adult, Breast Cancer
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: DE-iPTV radiotherapy

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.

Interventions

Radiation: - DE-iPTV

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

Contact a Trial Team

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