Breast Cancer Liquid Biopsy Trial

Breast Cancer Clinical Trial

Official title: Liquid vs Tissue Biopsy Concordance in Samples of 1st Suspected BCa Recurrence/Metastasis and Evaluation of DefineMBC Comprehensive Cancer Profiling Liquid Biopsy LDT

Status Recruiting

Clinical Trial Summary

The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.

Clinical Trial Description

An estimated 287,850 women will be diagnosed with invasive breast cancer in the US in 2022 (cancer.org). Most women with breast cancer present with disease confined to the breast and local lymph nodes, where surgical removal of lesions is standard of care and well-managed. Those diagnosed and treated for primary breast cancer often recur with metastatic disease more than 5 years after initial diagnosis. (Pan, NEJM 2017). Sadly, when lesions emerge in other areas, after months or decades with no evidence of disease, mortality rates rise. The most common sites of distant recurrence of breast cancer are the bone, lung, liver, and brain, (Lin, NCCN 2012), all of which are difficult to biopsy, and obtain pathological evidence of malignancy because metastatic lesions: 1) are not always accessible/deeply located, 2) are prone to under sampling, and 3) may present dense fibrotic tissue. In addition, tissue biopsy methods in metastatic lesions have been shown to: 1. have low patient compliance, 2. have high discordance rate with malignant lesions at imaging, 3. be incompatible with longitudinal monitoring. As a result, at a critical point in patient care, there is still a current unmet need for diagnostic information to guide decision-making. As established widely in published literature over the past decade, receptor status often changes between primary and metastatic disease, and during lines of metastatic treatments, changing the trajectory of the disease and further highlighting the need for longitudinal evaluation of receptor status. Occult micro-metastases or minimal residual disease (MRD) cannot be detected with current medical modalities and can originate metastatic relapse at distant sites. For this reason, cellular and molecular liquid biopsy approaches that enable detection of disease relapse allow therapy escalation many months earlier than overt relapse detected by imaging which as result may increase patients' survival. Based on discussions, interviews, and surveys of both thought-leading academics and community-based medical oncologists, there is an evident opportunity to improve patient care. Moreover, the market shows receptivity to a blood-based test for these inaccessible cases as well as improve identification of patients at high risk of relapse or eligible for earlier treatment escalation compared to current tissue biopsy testing in practice today. In this clinical trial the purpose is to examine the potential of blood draws as a rapid and less invasive alternative to biopsies. Additionally, to compare the results of Epic Sciences' liquid biopsy test, DefineMBC, with results of standard-of-care (SoC) pathology results from metastatic contemporaneous tissue biopsies. With the implementation of our newest Registry Arm of patients, our goal is also to provide participating physician investigators the results Epic Sciences' liquid biopsy test, Define MBC, for breast cancer subjects with no central pathology data and utilize physician feedback for test experience improvements. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer

• NCT number: NCT04962529
• Study type: Observational
• Source: Protean BioDiagnostics
• Contact: Hannah Park, BS
• Phone: (754) 241-4209
• Email: hannah.park@proteanbiodx.com
• Status: Recruiting
• Start date: September 28, 2020
• Completion date: July 31, 2023