Biocept Inc (NASDAQ:BIOC) said it is participating in a study evaluating biomarkers associated with central nervous system (CNS) metastasis in patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease.
The study will look at cerebrospinal fluid tumor and the immune cell microenvironment to better understand treatment response, prognosis, and treatment resistance that may improve the management of CNS disease in patients with metastatic breast cancer, the company said.
The study is being conducted by breast oncologists Dr Michelle E Melisko and Dr Laura A Huppert at the University of California, San Francisco (UCSF), under a grant from the California Breast Cancer Research Program and the UCSF Brain Spore.
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Results from cerebrospinal fluid using Biocept’s CNSide assay and matched patient blood samples will be analyzed and compared to detect and characterize cancer in the cerebrospinal fluid with the goal of identifying new targets and to guide therapeutic decisions, the company said.
Biocept also said Huppert and Melisko will work with Dr Chris Im in the laboratory of Dr Max Krummel at UCSF to examine the immune-cell microenvironment in a companion study, and the results will be analyzed together.
“We hypothesize that patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease will have tumor cells and cell-free tumor DNA (ctDNA) that can be detected in cerebrospinal fluid, and that higher concentrations of cerebrospinal fluid tumor cells and ctDNA will correlate with progression of brain metastases and/or development of leptomeningeal disease,” Melisko said in a statement.
“The ability to identify cancer biomarkers that predict an elevated risk of CNS disease progression will have prognostic and therapeutic implications in treating these patients.”
Biocept’s chief medical officer and medical director Dr Michael Dugan said the study is designed to provide important information derived from cerebrospinal fluid samples that will better inform physicians treating patients with metastatic breast cancer involving the CNS, in particular those with leptomeningeal disease, who have a very poor prognosis if untreated.
“CNSide will help these physicians determine the extent of involvement, potential targets for treatment and help them evaluate the response to treatment,” Dugan said.
“This study will also evaluate and compare the information derived from cerebrospinal fluid versus that of matched blood samples, where – based on our early experience – we believe cerebrospinal fluid could be more informative of intracranial response to treatment than related blood-based tests or radiologic changes routinely assessed by MRI,” Dugan said.
The pilot study will collect cerebrospinal fluid and blood samples from 20 patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease.
One of the most devastating complications of metastatic breast cancer is the development of CNS disease, including brain metastases and/or leptomeningeal disease. Among patients with metastatic breast cancer, approximately 15% to 45% develop brain metastases and approximately 5% to 10% develop leptomeningeal disease during the course of their disease, resulting in significant morbidity and mortality. As patient outcomes improve with better systemic treatment options, control of CNS disease has become increasingly important to reduce morbidity and prolong survival, according to Biocept.
Patients with leptomeningeal disease are often excluded from clinical trials and there are few effective treatments. In order to develop better tools for the diagnosis and treatment of metastatic breast cancer with CNS disease, it is critical to better understand the biology of this condition. Specifically, the profiling of the cerebrospinal fluid tumor and immune microenvironment in patients with brain metastases and/or leptomeningeal disease will enable a better understanding of the characteristics that may contribute to the development and progression of CNS disease, according to the company.
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