Biocept Announces Participation in an Investigator-Initiated Study to Better Understand the Development and Progression of Metastatic Breast Cancer to the Central Nervous System
Conducted by leading breast oncologists from UCSF under a grant from the California Breast Cancer Research Program and the
The study is being conducted by breast oncologists
“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,” said
“This collaborative 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,” 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,” he added.
The pilot study will collect cerebrospinal fluid and blood samples from 20 patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The samples will be analyzed for the presence, quantity and mutational profile of cerebrospinal fluid ctDNA and cerebrospinal fluid tumor cells, which will be paired with results from peripheral blood mononuclear cell samples. Exploratory analysis of changes in cerebrospinal fluid ctDNA, tumor cell, and immune cell characteristics will be performed over time in a limited number of serial samples. The cerebrospinal fluid findings will then be correlated with clinical outcomes, including CNS disease progression and survival.
The Rationale for the Study
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 15-45% develop brain metastases and approximately 5-10% 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.
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.
About the California Breast Cancer Research Program
The mission of the California Breast Cancer Research Program (CBCRP) is to prevent and eliminate breast cancer by leading innovation in research, communication, and collaboration in the
CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the central nervous system, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to be correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," “goal,” or "project," or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this press release are not strictly historical, including, without limitation, statements regarding the study design and its potential results, benefits and other outcomes, our hypotheses, the prognostic and therapeutic implications of the ability to identify biomarkers that predict an elevated risk of CNS disease progression, and the ability of CNSide to detect, characterize and monitor disease progression in patients with leptomeningeal disease, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risks and uncertainties, including with the risk that the study described in this press release does not provide clinically meaningful data, does not confirm our hypothesis or otherwise does not demonstrate the clinical value of our CNSide assay for the diagnosis and treatment of the patients in the study, and the risk that our products and services may not perform as expected. These and other factors are described in greater detail under the "Risk Factors" heading of Biocept’s Quarterly Report on Form 10-Q for the quarter ended
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