Breast Cancer
Conditions
Keywords
HER2, Triple Negative, Brain Metastasis
Brief summary
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: 1. What proportion of patients with stage IIb or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (MRI) of the brain? 2. How do patients feel about undergoing brain imaging to screen for asymptomatic brain metastasis? 3. What clinical as well as liquid and tissue-based biomarkers are associated with asymptomatic detection of brain metastasis? 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.
Interventions
DIAGNOSTIC_TESTBrain imaging
Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)
DIAGNOSTIC_TESTAnalysis of circulating tumor DNA
Blood draw for analysis of circulating tumor DNA
BEHAVIORALTesting Morbidities Index
Questionnaire regarding the participant's perception of brain imaging.
Sponsors
Princess Margaret Hospital, Canada
MOUNT SINAI HOSPITAL
Trillium Health Partners
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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+).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18. 2. Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines). 3. Stage IIb 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic brain metastasis frequency among HER2+ patients | 18 months | Proportion of eligible patients with Stage IIb or III HER2+ breast cancer who have asymptomatic brain metastasis |
| Asymptomatic brain metastasis frequency among Triple Negative patients | 18 months | Proportion of eligible patients with Stage IIb or III Triple Negative breast cancer who have asymptomatic brain metastasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Acceptability of brain imaging to patients | 18 months | Proportion of patients who are approached about the study who agree to enroll |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory biomarkers | 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 future development of brain metastases when the study has been completed. |
| Correlation between circulating tumor DNA in the blood at enrollment and incidence of brain metastases at the end of the study | 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. |
Countries
Canada
Contacts
Primary ContactKatarzyna Jerzak, MD, M.Sc
Outcome results
None listed