Clinical trial · Interventional
BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DE-iPTV | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DE-iPTV radiotherapy
- description
- 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.
- interventionNames
- Radiation: DE-iPTV
Primary outcomes (1)
- 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
- timeFrame
- 8 weeks post-enrolment
- description
- Completion of radiotherapy and completion of EuroQol- 5 Dimension (EQ-5D-5L) questionnaire
Secondary outcomes (12)
- measure
- Lesional Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDChen 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