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.
Please see trial details below.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
50
A standard contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain will be performed at baseline, 4 months, 8 months and 12 months.
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
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.
This outcome is intended to assess the feasibility of a future large, multi-center randomized trial.
Time frame: 15 months.
Proportion of patients in the control arm who undergo imaging of the brain with CT or MRI.
This outcome is intended to assess the incidence of screening "contamination" in the control arm of the study.
Time frame: 12 months
Incidence of symptomatic brain metastases.
To be assessed in both study arms.
Time frame: Baseline, 4-, 8- and 12-months.
Number of interventions used to treat brain metastases.
To be assessed in both study arms.
Time frame: 15 months
Size and location of BrM per patient.
To be assessed in both study arms.
Time frame: 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).
To be assessed in both study arms; 37 questions are rated from a scale of 0 to 4 (total score 0 to 185 where a lower score indicates better quality-of-life)
Time frame: Baseline, 6 months and 15 months.
Overall quality-of-life (EORTC core quality of life questionnaire; EORTC QLQ-C30 version 3 tool).
To be assessed in both study arms; ; 30 questions are rated from a scale of 1 to 4 (total score 30 to 120 where a lower score indicates better quality-of-life)
Time frame: Baseline, 6 months and 15 months.
Cancer-related anxiety (NCI PRO-CTCAE for anxiety).
To be assessed in both study arms.
Time frame: Baseline, 6 months and 15 months.
Time to death due to any cause.
To be assessed in both study arms.
Time frame: 15 months.
Time to death due to neurologic progression.
To be assessed in both study arms.
Time frame: 15 months.
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