NCT06611306 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Brain Metastases, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2026-06-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06611306 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 100 Years, studying Brain Metastases, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06611306 currently recruiting?
Yes, NCT06611306 is actively recruiting participants. Contact the research team at beat-breast@imperial.ac.uk for enrollment information.
Where is the NCT06611306 trial being conducted?
This trial is being conducted at London, United Kingdom, Oxford, United Kingdom.
Who is sponsoring the NCT06611306 clinical trial?
NCT06611306 is sponsored by Imperial College London. The trial plans to enroll 42 participants.