Routine MRI Screening Versus Symptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative and HER2+ Metastatic Breast Cancer (MBC): a Single-centre Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol.
研究概览
简要总结
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre. They will be randomized to undergo either routine MRI screening of their brain every 4 months for 1 year or standard-of-care (MRI only if symptoms of brain metastases develop). Patients will complete questionnaires about quality of life and cancer-related anxiety throughout the study. To determine why some cancers spread to the brain and others do not, blood samples will be collected to analyze the genetic makeup of patients' breast cancers. Finally, a novel MRI imaging technique that detects abnormal metabolism in the brain will be used to help detect brain metastases even earlier than the standard MRI.
If results are promising, we will conduct a large multi-centre randomized trial to determine whether screening for brain metastases can help them live longer with improved quality of life.
详细描述
Please see trial details below.
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
- 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 (ASCO/CAP guidelines 2018)*
- •MBC, as defined as distant disease outside of the breast and local/regional lymph nodes. Physicians' clinical judgment will be used to determine the possible need for biopsy in confirming a MBC diagnosis. However, biopsy of a metastatic site is not required for pathologic confirmation of stage IV disease.
- •Diagnosis of metastatic disease within 12 weeks prior to study enrollment.
- •No symptoms of BrM or known asymptomatic BrM at study entry.
- •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.
- •This will generally be based on the primary cancer but in the event that a metastatic site is biopsied eligibility will be based on the ER, PR and HER2 profile of the metastasis.
排除标准
- •Inability to participate in an MRI screening program as determined by the patient and/or physician. This may be on the basis of severe claustrophobia, performance status that limits additional testing, or a metal foreign body that would prevent MRI imaging.
- •Inability to provide informed consent. Notably participants who require translators are allowed to enroll.
- •Creatinine clearance <30 mL/min using the Cockcroft-Gault equation.
- •Established need for brain imaging apart from the breast cancer diagnosis (e.g surveillance for an aneurysm).
- •ECOG Performance status >
- •Grade 3+ allergy to Gadavist IV contrast (CTEP Adverse Event Reporting System).
研究组 & 干预措施
MRI screening
Contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months.
干预措施: MRI screening (Diagnostic Test)
Symptom-directed surveillance
Imaging of the brain will take place only if patients develop symptoms that are suggestive of brain metastases (e.g. headaches, vision changes, gait instability).
结局指标
主要结局
Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol.
时间窗: 15 months.
This outcome is intended to assess the feasibility of a future large, multi-center randomized trial.
次要结局
- Time to death due to any cause.(15 months.)
- Number of interventions used to treat brain metastases.(15 months)
- Overall quality-of-life (EORTC core quality of life questionnaire; EORTC QLQ-C30 version 3 tool).(Baseline, 6 months and 15 months.)
- Proportion of patients in the control arm who undergo imaging of the brain with CT or MRI.(12 months)
- Size and location of BrM per patient.(At the time of diagnosis of brain metastases (from enrollment to 15 months))
- Neurologic-specific quality-of-life (The Functional Assessment of Cancer Therapy-Brain; FACT-BR version 4 tool).(Baseline, 6 months and 15 months.)
- Cancer-related anxiety (NCI PRO-CTCAE for anxiety).(Baseline, 6 months and 15 months.)
- Incidence of symptomatic brain metastases.(Baseline, 4-, 8- and 12-months.)
- Time to death due to neurologic progression.(15 months.)
研究者
Dr. Katarzyna Jerzak
Medical Oncologist and Clinician Investigator
Sunnybrook Health Sciences Centre