Method, Array and Use Thereof

Abstract

The present invention provides a method for the prognosis of breast cancer in a subject comprising the steps of: (a) providing a first proteome sample from the subject; (b) measuring in the first proteome sample the amount of one or more biomarkers selected from the group of biomarkers listed in Table 1; (c) providing an additional (e.g. a second) proteome sample from the subject; (d) measuring in the additional proteome sample the amount of the one or more biomarkers selected from the group of biomarkers listed in Table 1 measured in step (b); and (e) determining the difference between the amount of the one or more biomarkers in the first and additional proteome samples; wherein the first proteome sample and additional proteome sample are representative of the proteome composition of the subject on different days, and wherein the difference between the amount of the one or more biomarkers in the first and additional (e.g. second) proteome samples is indicative of the risk of recurrence and / or metastasis of the breast cancer in the subject. In further embodiments, step (b) comprises measuring the amount of each the biomarkers listed in Table 1(A) or all of the biomarkers listed in Table 1. The present invention additionally provides an array for performing the method of the invention, the use in vitro of a biomarker selected from the group of biomarkers in Table 1 as a prognostic marker for determining risk of recurrence and / or metastasis of breast cancer in a subject, and a kit for performing the method of the invention comprising one or more binding agents capable of binding to a biomarker listed in Table 1.

Description

FIELD OF INVENTION[0001]The present invention relates to methods for the prognosis of breast cancer and biomarkers and arrays for use in the same.BACKGROUND[0002]Breast cancer is one of the most common tumor types in the Western world, affecting more then every tenth woman (1). One fourth of all malignant diagnoses are for breast cancer and since late 1990 the incidence worldwide, especially for the age group 45 to 70, has been increasing, although there has been a slight decline during the past few years. One explanation for the decrease is that early screening activities (mammography) and endocrine and cytostatic therapies have improved survival.[0003]In spite of this decline, breast cancer still kills over one hundred women every day in the United States. Furthermore, despite improvements in early detection and understanding of the molecular basis of breast cancer, approximately 30% of all patients with primary breast cancer will develop distant recurrence of the disease (i.e. me...

AI Technical Summary

Benefits of technology

The patent describes a method to create smaller fragments of antibodies that have improved pharmacological properties. These fragments, such as Fab, Fv, ScFv, and dAb, can be easily produced by expressing and secreting them from Escherichia coli. The method does not require the production of whole antibodies, which can have additional functions and may not be necessary for some applications. Overall, this method allows for the efficient production of large quantities of antibody fragments.

Problems solved by technology

Once metastatic disease develops, the possibility of a cure is very limited or non-existing.

Today, there are only limited possibilities to predict disease outcome using traditional clinical predictors, such as histological grade and lymph node status (3, 4).

However, despite tremendous efforts it is presently not possible to perform risk assessments for breast cancer metastasis using a simple blood test, although recent developments in affinity proteomics have advanced the field of cancer biomarkers (7-9).

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