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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

Status: Recruiting

Location: See location...

Intervention Type: Diagnostic test

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 16

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

RECRUITING

Liverpool

Contact Information

Primary

Carlo Palmieri

c.palmieri@nhs.net

0151 556 5000

Time Frame

Start Date: 2025-10-03

Estimated Completion Date: 2027-12-31

Participants

Target number of participants: 69

Treatments

No_intervention: Arm 1: No Further Surveillance Brain MRI (Control)

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.

Experimental: Arm 2: Surveillance Brain MRI

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.

Related Therapeutic Areas

Breast Cancer

HER-2 Positive Breast Cancer

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