BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
- Conditions
- Brain Metastases, AdultBreast Cancer
- Interventions
- Radiation: DE-iPTV
- Registration Number
- NCT06611306
- Lead Sponsor
- Imperial College London
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DE-iPTV radiotherapy DE-iPTV 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.
- Primary Outcome Measures
Name Time Method 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 8 weeks post-enrolment Completion of radiotherapy and completion of EuroQol- 5 Dimension (EQ-5D-5L) questionnaire
- Secondary Outcome Measures
Name Time Method Lesional Response 8 weeks Lesional response and intracranial progression measured using RANO-BM criteria
Intracranial progression 6 months Intracranial progression based on RANO-BM
Treatments Within 6 months of enrolment Use of further brain-directed therapies (reported by clinician)
Central Nervous System (CNS) Failures Within 6 months of enrolment Time to CNS failure (either lesional progression or developing a new lesion as per RANO-BM)
Neurological toxicities Within 6 months of enrolment Acute and late neurological/ CNS toxicity as assessed using CTCAE v5
Health Related Quality of Life Within 6 months of enrolment HRQoL over time (participants reported outcomes for descriptive analysis)
Time to deterioration in quality of life Within 6 months of enrolment 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)
Symptom Burden Within 6 months of enrolment Symptom burden assessed by collection of clinician-recorded toxicities
Steroid usage Within 6 months of enrolment Use of corticosteroids over time, assessed through clinician reports and patient diaries
Quality-Adjusted Life Year Within 6 months of enrolment Quality-Adjusted Life Year
Overall survival End of study Overall survival
Trial Locations
- Locations (1)
Imperial College London
🇬🇧London, United Kingdom