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| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
| Trillium Health Partners | OTHER |
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The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage IIb or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:
Participants will undergo brain imaging, provide one blood sample (for analysis of ctDNA), and complete the Testing Morbidities Index (TMI) questionnaire after imaging is done. Procedures may take place either prior to or after completion of (neo)-adjuvant systemic therapy; however, the study interventions must take place within 18 months of initial breast cancer diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening MRI | Experimental | One-time contrast-enhanced brain magnetic resonance imaging (MRI), blood draw for circulating tumor DNA and assessment via the Testing Morbidity Index (TMI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain imaging | Diagnostic Test | Contrast-enahanced Brain Magnetic Resonance Imaging (MRI) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic brain metastasis frequency among HER2+ patients | Proportion of eligible patients with Stage IIb or III HER2+ breast cancer who have asymptomatic brain metastasis | 18 months |
| Asymptomatic brain metastasis frequency among Triple Negative patients | Proportion of eligible patients with Stage IIb or III Triple Negative breast cancer who have asymptomatic brain metastasis | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of brain imaging to patients | Proportion of patients who are approached about the study who agree to enroll | 18 months |
| Patients' acceptability of the brain magnetic resonance imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarkers | Evaluate a possible correlation between the presence of circulating tumor DNA in the blood of patients at the time of study enrollment and future development of brain metastases when the study has been completed. | 36 months. |
| Correlation between circulating tumor DNA in the blood at enrollment and incidence of brain metastases at the end of the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna Jerzak, MD, M.Sc | Contact | 416-480-6100 | 5248 | katarzyna.jerzak@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Jerzak, MD, M.Sc | Sunnybrook Health Science Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Science Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
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Patients (30 with TN and 30 with HER2+ breast cancer) will be recruited initially as part of a 2-stage design. If at least 1 out of 30 recruited patients is diagnosed with a BrM (3.3% incidence), then an additional 70 patients will be recruited to characterize the risk of BrM among 100 patients in the relevant subgroup (TN and/or HER2+).
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| Analysis of circulating tumor DNA |
| Diagnostic Test |
Blood draw for analysis of circulating tumor DNA |
|
| Testing Morbidities Index | Behavioral | Questionnaire regarding the participant's perception of brain imaging. |
|
Patients' acceptability of the brain magnetic resonance imaging as evaluated by the "Testing Morbidities Index" (TMI)
| 18 months |
| 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 |
Evaluate a possible correlation between the presence of circulating tumor DNA in the blood of patients at the time of study enrollment and the incidence of brain metastases when the study has been completed. |
| 36 months. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008919 | Investigative Techniques |