HER2+ CNS Surveillance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorThe Clatterbridge Cancer Centre NHS Foundation Trust
About this trial
A multi-centre, randomised study, to determine the feasibility of recruiting men and women with metastatic HER2 positive breast cancer to a study with a baseline MRI scan followed by randomising to surveillance by two further six-monthly MRI scans versus no further surveillance of the brain. Qualitative research (focus groups and/or interviews) and monitoring of approach and consent with SEAR framework will be embedded within the trial to achieve the primary endpoint and explore challenges with study implementation and delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention for Arm 2: Brain MRI Surveillance
Diagnostic testContrast-enhanced magnetic resonance imaging (MRI) of the brain performed at baseline and, for participants assigned to the surveillance arm, repeated at 6 and 12 months to detect asymptomatic CNS metastases
Treatment groups
69 Participants
are divided into 2 treatment groupsGroup A: Arm 1: No Further Surveillance Brain MRI (Control)No intervention 0 interventions
Group B: Arm 2: Surveillance Brain MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI.
Feasibility of recruitment, measured as the proportion of approached eligible patients who consent to participate in a study involving baseline brain MRI and randomisation to CNS surveillance versus no surveillance.
Time frame
Up to 24 months (from first participant approach until recruitment completion, defined as 69 participants consented or 193 participants approached, whichever occurs first)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov