HER2+ CNS Surveillance

Официальное название

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

Обзор

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.

Подробное описание

Patients with metastatic breast cancer who are HER2+ (i.e. their cancer cells show an abnormally high level of HER2 proteins when tested) are at high risk of cancer spreading to the brain and central nervous system (CNS). The current standard of care is to monitor patients for symptoms indicative of such cancer spread. The motivation of the researchers is to investigate if surveillance through MRI scans of the brain with standard MRI contrast agents would allow detection of asymptomatic spread to the brain and CNS, and then earlier management of such spread.

Metastatic lesions in the brain and CNS can be treated or managed, including by neurosurgery, stereotactic radiosurgery (radiotherapy highly focussed on the observed volume of lesions) or other radiotherapy treatment plans.

The investigators are interested in surveillance plans of either a single MRI scan, or repeated MRI scans every 6 months for a year. The purpose of this research protocol is to look at the feasibility of running trials into the diagnostic value of such brain MRI scans. In order to assess the feasibility of such trials the primary research endpoint will be the proportion of patients agreeing to register to a study with baseline MRI and then randomisation to further MRIs or not. The proportion that agree and the feedback from patients about the reasons to participate or not will feed into the design and planning of future research protocols. There will be an embedded qualitative sub-study with interviews and/or focus groups discussing recruiting to and running such studies with patients and staff. The investigators also plan to collect data on diagnosis, management and clinical outcomes (given as secondary endpoints in the protocol) that will allow the outcomes for the patients on this study to be included in combined analyses with those of future studies.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI. [Срок оценки: Up to 24 months (from first participant approach until recruitment completion, defined as 69 participants consented or 193 participants approached, whichever occurs first)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Великобритания · 1 центр

• The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool

Идентификаторы

NCT: NCT07748598 · C1566 · 341272

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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