MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain imaging, Analysis of circulating tumor DNA, Testing Morbidities Index.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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 test Brain imaging
Contrast-enahanced Brain Magnetic Resonance Imaging (MRI) - Diagnostic test Analysis of circulating tumor DNA
Blood draw for analysis of circulating tumor DNA - Behavioral Testing Morbidities Index
Questionnaire regarding the participant's perception of brain imaging.
Primary outcome measures
- Asymptomatic brain metastasis frequency among HER2+ patients [Time frame: 18 months]
- Asymptomatic brain metastasis frequency among Triple Negative patients [Time frame: 18 months]
Secondary outcome measures (3)
- Acceptability of brain imaging to patients [Time frame: 18 months]
- Patients' acceptability of the brain magnetic resonance imaging [Time frame: 18 months]
- Proportion of patients who have subsequent brain magnetic resonance imaging [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- Age > 18.
- Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
- Stage IIb or III disease.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
- Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
- Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Canada · 1 center
- Sunnybrook Health Science Centre — Toronto
Identifiers
NCT: NCT06247449 · SUN#5967