MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Brain imaging; Diagnostic Test: Analysis of circulating tumor DNA; Behavioral: Testing Morbidities Index

• Registration Number: NCT06247449
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:

1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain?

2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis?

3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis?

Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-29
• Status Verified: 2024-01
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age > 18.
2. Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
3. Stage II or III disease.
4. 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.
5. Ability to understand and the willingness to sign a written informed consent document.

Read More

Exclusion Criteria

1. Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
2. Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
3. Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening MRI	Analysis of circulating tumor DNA	One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)
Screening MRI	Testing Morbidities Index	One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)
Screening MRI	Brain imaging	One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)

Primary Outcome Measures

Name	Time	Method
Asymptomatic brain metastasis frequency among Triple Negative patients	18 months	Proportion of eligible patients with Stage II or III Triple Negative breast cancer who have asymptomatic brain metastasis
Asymptomatic brain metastasis frequency among HER2+ patients	18 months	Proportion of eligible patients with Stage II or III HER2+ breast cancer who have asymptomatic brain metastasis

Secondary Outcome Measures

Name	Time	Method
Acceptability of brain imaging to patients	18 months	Proportion of patients who are approached about the study who agree to enroll
Proportion of patients who have subsequent brain magnetic resonance imaging	36 months	Annual chart review to determine the frequency of patients who have subsequent brain imaging performed after the first trial magnetic resonance imaging
Patients' acceptability of the brain magnetic resonance imaging	18 months	Patients' acceptability of the brain magnetic resonance imaging as evaluated by the "Testing Morbidities Index" (TMI)

Trial Locations

Locations (1)

Sunnybrook Health Science Centre; 🇨🇦 Toronto, Ontario, Canada