ELEANOR Biomarker Screening for Late ER+ Breast Cancer Recurrence
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Solution Overview
Problem
Current diagnostic markers are inadequate for predicting late recurrence of ER-positive breast cancer, which often occurs 5 years or more after surgery, and there is a need for methods to screen therapeutic drugs effectively for this type of recurrence.
Innovation Solution
The use of ELEANOR expression as a marker for predicting late recurrence of ER-positive breast cancer, through detection methods such as RNA-FISH and PCR, and the development of a test kit for ELEANOR detection, along with a method for screening therapeutic drugs by culturing cells expressing ELEANOR and using changes in ELEANOR and CD44 expression as indicators.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If Oncotype DX is used to evaluate breast cancer recurrence risk, then the treatment plan can be established with information on 21 genes, but it cannot predict late recurrence cases occurring 5 years or more after surgery
Solution Approach 1:
The patent segments the recurrence prediction into two distinct time periods: early recurrence (within 5 years) and late recurrence (5 years or more). By developing separate biomarker panels for each period, the invention achieves precise prediction for both timeframes, resolving the limitation of existing methods that could only predict early recurrence.
Solution Approach 2:
The patent extends the prediction capability from a single time dimension (early recurrence only) to multiple time dimensions by introducing late recurrence prediction. This is achieved through identifying specific biomarkers (e.g., CD44, ALDH1A1) that are particularly indicative of late recurrence risk, thereby adding a new temporal dimension to the prediction framework.
2Reliability
If endocrine therapy is extended from 5 years to 10 years for high-risk patients, then late recurrence can be prevented, but adverse effects such as menopausal symptoms, joint pain, and thrombosis increase
Solution Approach 1:
The patent applies local quality by identifying specific patient subgroups through biomarker profiling (e.g., high CD44 expression, high ALDH1A1 expression) who would benefit most from extended therapy. Rather than universally extending therapy to all patients, the invention tailors the treatment duration to individual biomarker profiles, thereby reducing unnecessary exposure to adverse effects while maintaining prevention effectiveness for high-risk patients.
Solution Approach 2:
The patent changes the decision parameter for therapy extension from generic clinical factors to specific molecular biomarkers (CD44, ALDH1A1, ELEANOR). This parameter change enables more precise identification of patients who truly need extended therapy, optimizing the balance between recurrence prevention and adverse effect minimization.
3Loss of time
If diagnostic markers are developed for late recurrence prediction, then early detection and treatment of recurrence can be achieved, but the complexity of testing and analysis increases
Solution Approach 1:
The patent extracts specific key biomarkers (CD44, ALDH1A1, ELEANOR) from the complex array of potential markers that could be used for late recurrence prediction. By focusing on a limited set of high-value markers with strong predictive power, the invention reduces testing complexity while maintaining high detection accuracy for late recurrence.
Data Source
AI summary
There are many cases of late recurrent breast cancer that recurs after 5 years or more after surgery. If a marker for determining a late recurrence risk can be found, it can lead to early detection and treatment of recurrence. The present inventors analyzed clinical specimens and found that the ELEANOR expression correlates with the late recurrence of breast cancers. The risk of late recurrence can be tested by analyzing the ELEANOR expression in a breast cancer primary lesion. It is also possible to screen therapeutic drugs for breast cancers by using ELEANOR expression as an indicator. Furthermore, siRNA and LNA that suppress ELEANOR expression can also function as therapeutic drugs for breast cancers.