Clinical trial NCT06247449: MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: HER2
Triple Negative
Brain Metastasis
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: MOUNT SINAI HOSPITAL
name: Trillium Health Partners
First posted: 2024-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Asymptomatic brain metastasis frequency among HER2+ patients
timeFrame: 18 months
measure: Asymptomatic brain metastasis frequency among Triple Negative patients
timeFrame: 18 months
Secondary outcomes:
measure: Acceptability of brain imaging to patients
timeFrame: 18 months
measure: Patients' acceptability of the brain magnetic resonance imaging
timeFrame: 18 months
measure: Proportion of patients who have subsequent brain magnetic resonance imaging
timeFrame: 36 months
Other outcomes:
measure: Correlation of baseline clinical, tissue-based and liquid biopsy (e.g. circulating tumor DNA) based biomarkers with the presence of asymptomatic brain metastasis
timeFrame: 18 months
measure: 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
timeFrame: 36 months
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Science Centre
name: Katarzyna Jerzak, MD, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: