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
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Science Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | MOUNT SINAI HOSPITAL, Princess Margaret Hospital, Canada, Trillium Health Partners |
Canada,
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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