MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC

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MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18. 2. Triple negative or HER2+ breast cancer (ASCO/CAP guidelines 2018)* 3. 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. 4. Diagnosis of metastatic disease within 12 weeks prior to study enrollment. 5. No symptoms of BrM or known asymptomatic BrM at study entry. 6. 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.

Exclusion Criteria:

1. 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. 2. Inability to provide informed consent. Notably participants who require translators are allowed to enroll. 3. Creatinine clearance <30 mL/min using the Cockcroft-Gault equation. 4. Established need for brain imaging apart from the breast cancer diagnosis (e.g surveillance for an aneurysm). 5. ECOG Performance status >2. 6. Pregnancy. 7. Grade 3+ allergy to Gadavist IV contrast (CTEP Adverse Event Reporting System).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03881605
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sunnybrook Health Sciences Centre
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Katarzya J Jerzak, MD MSc FRCPC
Principal Investigator Affiliation	University of Toronto
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer, HER2-positive Breast Cancer

Additional Details

Please see trial details below.

Arms & Interventions

Arms

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.

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).

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada

Status

Address

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N3M5

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