Clinical trial · Interventional
HER2+ CNS Surveillance
HER2-CNS SURVEILLANCE: A Study of the Feasibility of Randomising Women and Men With HER2 Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus no Surveillance
- 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)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| CNS | — | UNRESOLVED | — |
| Her 2 Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention for Arm 2: Brain MRI Surveillance | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm 1: No Further Surveillance Brain MRI (Control)
- description
- Participants undergo a baseline contrast-enhanced MRI of the brain. Participants with no evidence of CNS metastases on the baseline MRI are randomized to receive no further protocol-mandated surveillance brain MRI and continue standard clinical care. Management of any subsequently identified CNS disease is according to local standard practice.
- type
- EXPERIMENTAL
- label
- Arm 2: Surveillance Brain MRI
- description
- Participants undergo a baseline contrast-enhanced MRI of the brain. Participants with no evidence of CNS metastases on the baseline MRI are randomized to a surveillance strategy involving additional contrast-enhanced brain MRI scans at 6 and 12 months. If CNS metastases are detected or symptoms develop before a scheduled scan, subsequent management is according to local standard practice. 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.
- interventionNames
- Diagnostic Test: Intervention for Arm 2: Brain MRI Surveillance
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria Age 16 years or older. Male or female. Histologically or cytologically confirmed HER2-positive breast cancer with evidence of metastatic breast cancer. Estrogen receptor (ER) positive or negative disease. Visceral disease present. Receiving active HER2-directed therapy. ECOG Performance Status 0-2. Life expectancy greater than 6 months. Written informed consent and ability to comply with study procedures and follow-up. Exclusion Criteria History of brain metastases. History or evidence of leptomeningeal carcinomatosis. Symptoms suggestive of brain metastases. Inability to tolerate or undergo MRI scans. Bone-only metastatic disease. Significant medical condition or laboratory finding that would make study participation undesirable. Inability to provide informed consent.
References
Publications (0)
Data not yet available