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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Life expectancy greater than 6 months. Written informed consent and ability to comply with study procedures and follow-up.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Intervention for Arm 2: Brain MRI Surveillance (Diagnostic Test)
结局指标
主要结局
Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI.
时间窗: Up to 24 months (from first participant approach until recruitment completion, defined as 69 participants consented or 193 participants approached, whichever occurs first)
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.
次要结局
未报告次要终点