MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients With Triple Negative or HER2+ MBC (SYMPToM)
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|ClinicalTrials.gov Identifier: NCT03881605|
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Brain Metastases Triple Negative Breast Cancer HER2-positive Breast Cancer||Diagnostic Test: MRI screening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 8, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: MRI screening
Contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months.
Diagnostic Test: MRI screening
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.
No Intervention: 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).
- 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. [ Time Frame: 15 months. ]This outcome is intended to assess the feasibility of a future large, multi-center randomized trial.
- Proportion of patients in the control arm who undergo imaging of the brain with CT or MRI. [ Time Frame: 12 months ]This outcome is intended to assess the incidence of screening "contamination" in the control arm of the study.
- Incidence of symptomatic brain metastases. [ Time Frame: Baseline, 4-, 8- and 12-months. ]To be assessed in both study arms.
- Number of interventions used to treat brain metastases. [ Time Frame: 15 months ]To be assessed in both study arms.
- Size and location of BrM per patient. [ Time Frame: At the time of diagnosis of brain metastases (from enrollment to 15 months) ]To be assessed in both study arms.
- Neurologic-specific quality-of-life (The Functional Assessment of Cancer Therapy-Brain; FACT-BR version 4 tool). [ Time Frame: Baseline, 6 months and 15 months. ]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)
- Overall quality-of-life (EORTC core quality of life questionnaire; EORTC QLQ-C30 version 3 tool). [ Time Frame: Baseline, 6 months and 15 months. ]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)
- Cancer-related anxiety (NCI PRO-CTCAE for anxiety). [ Time Frame: Baseline, 6 months and 15 months. ]To be assessed in both study arms.
- Time to death due to any cause. [ Time Frame: 15 months. ]To be assessed in both study arms.
- Time to death due to neurologic progression. [ Time Frame: 15 months. ]To be assessed in both study arms.
- Proportion of patients with changes in CEST imaging that are suggestive of brain metastases prior to confirmation on contrast-enhanced MRI imaging. [ Time Frame: Baseline, 4-, 8- and 12-months. ]Exploratory outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881605
|Contact: Katarzya J Jerzak, MD MSc FRCPC||4164806100 ext email@example.com|
|Contact: Ellen Warner, MD FRCPC MSc||4164806100 ext firstname.lastname@example.org|
|Sunnybrook Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Michael Julius, PhD 4164806100 email@example.com|
|Sub-Investigator: Ellen Warner, MD FRCPC MSc|
|Sub-Investigator: Arjun Sahgal, MD FRCPC|
|Sub-Investigator: Greg Stanisz, PhD|
|Principal Investigator:||Katarzya J Jerzak, MD MSc FRCPC||University of Toronto|