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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06247449
Other study ID # SUN#5967
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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