# US 9,771,618 B2 · Methods for treating breast cancer

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- Number: US 9,771,618 B2
- Document ID: US9771618B2
- Status: Granted
- Kind: B2
- Application number: 12/859,703
- Filed: 2010-08-19
- Published: 2011-02-24
- Granted: 2017-09-26
- Earliest claimed: 2009-08-19
- Assignees: Bioarray Genetics, Inc.
- Applicants: Marcia V. Fournier; Katherine J. Martin
- Inventors: Marcia V. Fournier; Katherine J. Martin
- Web page: https://patentgrep.com/patent/US9771618B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A01N 61/00: Biocides, pest repellants or attractants, or plant growth regulators containing substances of unknown or undetermined composition, e.g. substances characterised only by the mode of action
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- 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
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS

## Abstract

Clinical tests for testing therapeutic sensitivity of cancerous breast tissue and methods and kits for performing the same are described herein. Embodiments of the present invention are directed to methods for predicting the efficacy of treatment of breast cancer. In addition, certain embodiments are directed to a kit for testing therapeutic sensitivity of breast cancer tissue.

## Claims

### Claim 1

A method of treating a human subject with breast cancer with a taxane, wherein the taxane has been identified as being predicted to be efficacious for the human subject, the method comprising:
measuring RNA expression from a human breast cancer tissue sample by using a microarray or amplification process of a set of genes consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, and ODC1 to produce an RNA expression profile of the set of genes;
performing hierarchical clustered analysis on the produced RNA expression profile from the human breast cancer tissue to a hierarchical clustered dataset comprising patients that have responded to the taxane, wherein the hierarchical clustered dataset is a gene expression profile set consisting of ASPM, NCAPG, CDKN3, AEIRKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, and ODC1;
predicting that the taxane will be efficacious for the subject if the RNA expression profile from the human breast cancer tissue sample matches the hierarchical clustered dataset comprising patients that have responded to a taxane; and
administering a therapeutically effective amount of the taxane to the human subject that has been identified as being predicted to be efficacious for taxane treatment.

### Claim 2 (depends on 1)

The method of claim 1, further comprising administering radiation to the subject.

### Claim 3 (depends on 1)

The method of claim 1, further comprising administering an alkylating agent, an antimetabolite, an anthracycline, an anti-mitotic agent, a topoisomerase I inhibitor, a topoisomerase II inhibitor, a corticosteroid or any combination thereof.

### Claim 4 (depends on 1)

The method of claim 1, further comprising generating a report indicating the efficacy of the treatment.

### Claim 5 (depends on 1)

The method of claim 1 wherein the taxane is docetaxel.

### Claim 6 (depends on 1)

The method of claim 1 wherein the taxane is paclitaxel.

### Claim 7 (depends on 1)

The method of claim 1, further comprising obtaining a breast cancer tissue sample from the subject.

### Claim 8 (depends on 1)

The method of claim 1, wherein the amplifying step comprises performing PCR.

### Claim 9 (depends on 1)

The method of claim 1, wherein the breast cancer is negative for expression of estrogen receptor, progesterone receptor and HER2/neu (erbb2) receptor.

### Claim 10 (depends on 1)

The method of claim 1, wherein the breast cancer is positive for expression of estrogen receptor.