This clinical trial evaluates using magnetic resonance imaging (MRI) and lumbar punctures (LP) to monitor for cancer spread to the central nervous system (CNS, which includes the brain and spine) in patients with stage II-IV HER2 positive breast cancer. When cancer cells make too much (overexpress) HER2, a protein that plays a role in the growth of cancer cells, the protein causes these cells to divide and grow uncontrollably. Performing MRI scans of the brain and testing cerebrospinal fluid (CSF) with a LP in patients with HER2-positive metastatic or advanced breast cancer may be an effective way of identifying the early onset of CNS metastases (such as brain cancer).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05130840.
PRIMARY OBJECTIVE:
I. To determine feasibility of multi-modality diagnostic evaluation in stage IV HER2+ breast cancer patients as well as stage II-III HER2+ breast cancer patients with no known CNS metastases.
SECONDARY OBJECTIVES:
I. To assess the proportion of eligible patients completing multiple evaluations (MRI, CSF) within 12 months.
II. To estimate the concordance of CNS disease positivity as determined by MRI, cytology, and CSF cell free deoxyribonucleic acid (cfDNA).
III. To determine the rate of adverse events associated with study investigations (MRI, LP).
EXPLORATORY OBJECTIVES:
I. To correlate baseline CSF circulating tumor cells (CTCs) and cfDNA to CNS metastases formation.
II. To correlate repeated presence of CSF CTCs and cfDNA to CNS metastases formation.
III. Compare the molecular characterization of primary breast tissue for those with available next generation sequencing to CSF results.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients with stage IV HER2+ breast cancer undergo LP, MRI with and without gadolinium intravenously (IV) at screening, 6 months and 12 months. Patients who have already undergone standard of care (SOC) MRI within 2 months of study enrollment do not undergo screening MRI. Patients also undergo blood and CSF sample collection on study.
COHORT II: Patients with stage II-III HER2+ breast cancer without CNS metastases undergo LP, MRI with and without gadolinium IV at screening, 6 months, and 12 months. Patients who have already undergone SOC MRI within 2 months of study enrollment do not undergo screening MRI. Patients also undergo blood and CSF sample collection on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJessica A Wilcox
