MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Asymptomatic brain metastasis frequency among HER2+ patients
研究概览
简要总结
The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage IIb or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:
- What proportion of patients with stage IIb or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (MRI) of the brain?
- How do patients feel about undergoing brain imaging to screen for asymptomatic brain metastasis?
- What clinical as well as liquid and tissue-based biomarkers are associated with asymptomatic detection of brain metastasis?
Participants will undergo brain imaging, provide one blood sample (for analysis of ctDNA), and complete the Testing Morbidities Index (TMI) questionnaire after imaging is done. Procedures may take place either prior to or after completion of (neo)-adjuvant systemic therapy; however, the study interventions must take place within 18 months of initial breast cancer diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
- •Stage IIb or III disease.
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may participate.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
- •Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
- •Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
结局指标
主要结局
Asymptomatic brain metastasis frequency among HER2+ patients
时间窗: 18 months
Proportion of eligible patients with Stage IIb or III HER2+ breast cancer who have asymptomatic brain metastasis
Asymptomatic brain metastasis frequency among Triple Negative patients
时间窗: 18 months
Proportion of eligible patients with Stage IIb or III Triple Negative breast cancer who have asymptomatic brain metastasis
Asymptomatic brain metastasis frequency among HER2+ patients
时间窗: 18 months
Proportion of eligible patients with Stage IIb or III HER2+ breast cancer who have asymptomatic brain metastasis
Asymptomatic brain metastasis frequency among Triple Negative patients
时间窗: 18 months
Proportion of eligible patients with Stage IIb or III Triple Negative breast cancer who have asymptomatic brain metastasis
次要结局
- Acceptability of brain imaging to patients(18 months)
- Proportion of patients who have subsequent brain magnetic resonance imaging(36 months)
- Patients' acceptability of the brain magnetic resonance imaging(18 months)