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William J. Gradishar, MD, FACP, FASCO


Study to Explore Multimodality CNS Surveillance in Patients With HER2-Positive Breast Cancer

By: Angela Lorio
Posted: Monday, September 18, 2023

A trial currently enrolling patients with HER2-positive breast cancer is investigating whether a combination of MRI and cerebrospinal fluid (CSF) assessment can provide earlier detection of central nervous system (CNS) metastasis. It is reportedly the first feasibility study of a multimethod screening approach in this patient population. Rachna Malani, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues introduced the details of their study during a trials in progress session at the 2023 joint Society for Neuro-Oncology (SNO)/American Society of Clinical Oncology (ASCO) CNS Cancer Conference (Abstract TIPS-10).

Routine surveillance for CNS disease among patients with breast cancer is currently not recommended, according to the investigators. The research team stressed that the challenges and impact posed by the high rate of CNS metastasis among patients with HER2-positive breast cancer suggest the threshold for imaging and CSF analysis is low. From 25% to 48% of patients with HER2-positive breast cancer develop CNS metastasis; these rates trend higher when the presence of stage IV disease and increased lines of HER2-positive–directed therapy are also considered.

The open-label, nonrandomized trial will observe two patient cohorts (no known CNS metastases), with parallel assignment according to stage IV (cohort A) or stage II or III (cohort B) disease. Patients will undergo MRI brain and CSF analysis (ie, cytology, circulating tumor cells, cell-free DNA) assessments at screening and at two 6-month intervals. The study plans to enroll a total of 20 patients and requires an 80% completion of MRI and CSF assessments at 2 years in each cohort.

Dr. Malani and colleagues have enrolled four patients since the trial’s July 2022 launch. For more on this recruiting trial, visit

Disclosure: The study authors reported no conflicts of interest.

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