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HER2+ CNS Surveillance

NCT07748598 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Her 2 Positive Breast Cancer
  • Cancer
  • CNS

Interventions

DIAGNOSTIC_TEST

Intervention for Arm 2: Brain MRI Surveillance

Contrast-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

Sponsors & Collaborators

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07748598 on ClinicalTrials.gov