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

Breast Cancer Clinical Trial

Official title:

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247449
• Other study ID #: SUN#5967
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: June 1, 2028

Study information

• Verified date: January 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Katarzyna Jerzak, MD, M.Sc
• Phone: 416-480-6100
• Email: katarzyna.jerzak[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• Brain imaging
Brain Magnetic resonance (or computed tomography if magnetic resonance is contraindicated)
• Analysis of circulating tumor DNA
One single blood draw for analysis of circulating tumor DNA

Behavioral:
• Testing Morbidities Index
Questionnaire regarding the participant's perception of brain imaging.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Science Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	MOUNT SINAI HOSPITAL, Princess Margaret Hospital, Canada, Trillium Health Partners

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of baseline clinical, tissue-based and liquid biopsy (e.g. circulating tumor DNA) based biomarkers with the presence of asymptomatic brain metastasis	Correlation between initial clinical and pathological staging with the rate of asymptomatic brain metastasis as seen in the brain MRI Correlation of positive liquid biopsy (e.g. circulating tumor DNA) with the rate of asymptomatic brain metastasis as seen in the brain MRI	18 months
Other	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 between initial clinical and pathological staging with the rate of future development of brain metastasis at the 1-year, 2-year and 3-year time points as captured by chart review.; Correlation of positive liquid biopsy (e.g. circulating tumor DNA) with the rate of future development of brain metastasis at the 1-year, 2-year and 3-year time points as captured by chart review.	36 months
Primary	Asymptomatic brain metastasis frequency among HER2+ patients	Proportion of eligible patients with Stage II or III HER2+ breast cancer who have asymptomatic brain metastasis	18 months
Primary	Asymptomatic brain metastasis frequency among Triple Negative patients	Proportion of eligible patients with Stage II or III Triple Negative breast cancer who have asymptomatic brain metastasis	18 months
Secondary	Acceptability of brain imaging to patients	Proportion of patients who are approached about the study who agree to enroll	18 months
Secondary	Patients' acceptability of the brain magnetic resonance imaging	Patients' acceptability of the brain magnetic resonance imaging as evaluated by the "Testing Morbidities Index" (TMI)	18 months
Secondary	Proportion of patients who have subsequent brain magnetic resonance imaging	Annual chart review to determine the frequency of patients who have subsequent brain imaging performed after the first trial magnetic resonance imaging	36 months