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Abstract BACKGROUND The incidence of asymptomatic brain metastasis (BrM) among patients with early-stage HER2+ and Triple Negative (TN) breast cancer (BC) is not well understood. Our goal is to determine the proportion of patients with stage II or III HER2+ or TN BC who have asymptomatic BrM identified on a screening contrast-enhanced MRI of the brain in a prospective clinical trial. METHODS A phase II, single-arm, multi-centre, conducted in Ontario, Canada (NCT06247449). One hundred patients (50 with HER2+ and 50 with TN disease) are being recruited over 24-months. Key inclusion criteria: i) age ≥18; ii) HER2+ or TN BC (2018 ASCO/CAP guidelines); iii) stage II or III disease. Key exclusion criteria: i) symptoms suggestive of BrM which would otherwise require imaging; ii) known asymptomatic BrM; iii) pregnancy. Patients will undergo a contrast-enhanced MRI of the brain (or contrast-enhanced CT if MRI is not possible), blood collection for ctDNA analysis, and completion of the Testing Morbidities Index (TMI) questionnaire within 4 weeks of recruitment. Interventions must be performed within 12 months of original BC diagnosis and within 6 weeks of starting post-operative adjuvant therapy. Co-primary endpoints: i) the proportion of eligible patients with stage II or III HER2+ BC who have asymptomatic BrM, and ii) the proportion of eligible patients with stage II or III TN BC who have asymptomatic BrM. Secondary endpoints: the proportion of patients who are approached about the study who agree to enroll; patients’ acceptability of the brain imaging as evaluated by the TMI; and the proportion of patients who have subsequent brain MRIs after the initial trial MRI. The association of baseline clinical, tissue-based, and ctDNA based biomarkers with the presence of asymptomatic BrM at initial staging and with future development of BrM at 1-year, 2-year and 3-years (captured by chart review) will also be assessed.
Fernandes et al. (Thu,) studied this question.