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

NCT ID: NCT03881605

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-08
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

Please see trial details below.

Conditions

Breast Neoplasm; Brain Metastases; Triple Negative Breast Cancer; HER2-positive Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

MRI screening

Contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months.

Group Type: EXPERIMENTAL

MRI screening

Intervention Type: DIAGNOSTIC_TEST

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard University

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Katarzyna Jerzak

Medical Oncologist and Clinician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katarzya J Jerzak, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

211-2018

Identifier Type: -

Identifier Source: org_study_id