# US 11,306,363 B2 · Prognosis biomarkers for triple-negative breast cancer

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- Number: US 11,306,363 B2
- Document ID: US11306363B2
- Status: Granted
- Kind: B2
- Application number: 16/915,254
- Filed: 2020-06-29
- Published: 2021-12-30
- Granted: 2022-04-19
- Earliest claimed: 2020-06-29
- Assignees: National Chiao Tung University
- Applicants: National Chiao Tung University
- Inventors: Kuang-Wen Liao; Hsien-Da Huang; Hsiao-Chin Hong; Cheng-Hsun Chuang
- Web page: https://patentgrep.com/patent/US11306363B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- C12Q 2600/178: miRNA, siRNA or ncRNA
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

A microRNA (miRNA) expression signature for predicting triple-negative breast cancer (TNBC) recurrence is provided. The miRNA expression signature consists essentially of hsa-miR-139-5p, hsa-miR-10b-5p, hsa-miR-486-5p, hsa-miR-455-3p, hsa-miR-107, hsa-miR-146b-5p, hsa-miR-324-5p, and hsa-miR-20a-5p.

## Claims

### Claim 1

A method of predicting a risk of cancer recurrence in a triple-negative breast cancer (TNBC) patient by a signature of miRNA gene products, the method comprising:
providing a breast cancer sample from the TNBC patient, the breast cancer sample negatively expressing biomarkers comprising estrogen (ER), progesterone (PR), and human epithelial receptor 2 (HER2) determined by immunohistochemical staining;
measuring an expression level of each of a combination of miRNAs in the breast cancer sample, wherein the combination of miRNAs consists of hsa-miR-139-5p, hsa-miR-10b-5p, hsa-miR-486-5p, hsa-miR-455-3p, hsa-miR-107, hsa-miR-146b-5p, hsa-miR-324-5p, and hsa-miR-20a-5p;
calculating a risk score based on the expression level of the miRNAs, wherein
the risk score=(0.02554×an expression value of miR-139)+(−0.000005284×an expression value of miR-10b)+(−0.0003305×an expression value of miR-486)+(0.008664×an expression value of miR-107)+(0.003201×an expression value of miR-324)+(0.001031×an expression value of miR-455)+(0.000474×an expression value of miR-146b)+(−0.001575×an expression value of miR-20a); and
comparing the risk score with a reference threshold of 1.602 to determine the risk of cancer recurrence of the TNBC patient, wherein the TNBC patient is predicted to have a high risk when the risk score is equal to or larger than 1.602.