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MRI Screening for Brain Metastases in Breast Cancer

N/A

Recruiting

Led By Katarzyna Jerzak, MD, M.Sc

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines)

Age > 18

Must not have

Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast)

Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how often patients with advanced types of breast cancer have undetected brain metastases. Participants will undergo brain imaging and provide a blood sample for analysis. They will also fill out

Who is the study for?

This trial is for people with stage II or III Triple Negative or HER2 positive breast cancer who haven't shown symptoms of brain metastasis. Participants must be within one year of their initial diagnosis and can join before or after systemic therapy.

What is being tested?

The study aims to find out how common asymptomatic brain metastases are in certain breast cancer patients by using MRI (or CT scans if MRI isn't possible), analyzing blood samples for tumor DNA, and assessing feelings about the screening process.

What are the potential side effects?

There may not be direct side effects from the interventions as they involve diagnostic procedures like imaging and blood tests. However, participants might experience discomfort or anxiety related to undergoing these procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is either Triple Negative or HER2 positive.

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I am older than 18 years.

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My condition is at stage II or III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low, with a creatinine clearance under 30 mL/min.

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I have symptoms that may suggest my cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asymptomatic brain metastasis frequency among HER2+ patients

Asymptomatic brain metastasis frequency among Triple Negative patients

Secondary study objectives

Acceptability of brain imaging to patients

Patients' acceptability of the brain magnetic resonance imaging

Proportion of patients who have subsequent brain magnetic resonance imaging

Other study objectives

Correlation of baseline clinical, tissue-based and liquid biopsy (e.g. circulating tumor DNA) based biomarkers with future development of brain metastasis at the 1-year, 2-year and 3-year time points as captured by chart review

Correlation of baseline clinical, tissue-based and liquid biopsy (e.g. circulating tumor DNA) based biomarkers with the presence of asymptomatic brain metastasis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening MRIExperimental Treatment3 Interventions

One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brain imaging

2017

N/A

~60

0 / 5Eligibility criteria met