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.
