# US 2018/0223369 A1 · Methods for predicting the efficacy of treatment

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- Number: US 2018/0223369 A1
- Document ID: US20180223369A1
- Status: Published application
- Kind: A1
- Application number: 15/680,969
- Filed: 2017-08-18
- Published: 2018-08-09
- Earliest claimed: 2009-08-19
- Assignees: Bioarray Genetics, Inc.
- Applicants: Bioarray Genetics, Inc.
- Inventors: Marcia V. FOURNIER; Katherine J. MARTIN
- Web page: https://patentgrep.com/patent/US20180223369A1

## 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 at position 1

1-16. (canceled)

### Claim 17

A method for predicting the efficacy of treatment of breast cancer comprising: analyzing an expression profile of marker genes from a cancerous breast tissue; and predicting the efficacy of treatment if the expression profile from the cancerous breast tissue matches a predetermined expression profile that indicates a patient will respond to the treatment wherein the marker gene is selected from a group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof.

### Claim 18 (depends on 17)

The method of claim 17 further comprising developing an expression profile from said marker genes.

### Claim 19 (depends on 17)

The method of claim 17, wherein the treatment is selected from a chemotherapeutic agent, radiation and a combination thereof.

### Claim 20 (depends on 19)

The method of claim 19, wherein the chemotherapeutic agent comprises alkylating agents, antimetabolites, anthracyclines, anti-tumor inhibitors, anti-mitotic agents, topoisomerase I inhibitors, topoisomerase II inhibitors, corticosteroids and combinations thereof.

### Claim 21 (depends on 17)

The method of claim 17 further comprising providing chemotherapy to said patients.

### Claim 22 (depends on 17)

The method of claim 17, further comprising generating a report indicating the likelihood of long-term survival without breast cancer recurrence in a patient.

### Claim 23

A kit for testing therapeutic sensitivity of breast cancer tissue comprising: a means for identifying the expression profile of a tissue sample having probes to a specific set of genes or proteins associated with the disease; and labels, reagents, and other materials or instructions for labeling and preparing reagents and other materials necessary to develop an expression profile of one or more marker genes.

### Claim 24 (depends on 23)

The kit of claim 23, wherein the marker gene is selected from a group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof.

### Claim 25

A method of identifying a breast cancer patient who is likely to respond to a treatment for breast cancer comprising: developing a genetic profile from marker genes from a breast tissue sample; and identifying a breast cancer patient as likely to respond to a treatment for breast cancer if the expression profile matches a predetermined expression profile that indicates that a patient will respond to the treatment wherein the marker gene is selected from the group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof.

### Claim 26 (depends on 25)

The method of claim 25, wherein the treatment is selected from a chemotherapeutic agent, radiation and a combination thereof.

### Claim 27 (depends on 26)

The method of claim 26, wherein the chemotherapeutic agent comprises alkylating agents, antimetabolites, anthracyclines, anti-tumor inhibitors, anti-mitotic agents, topoisomerase I inhibitors, topoisomerase II inhibitors, corticosteroids and combinations thereof.

### Claim 28 (depends on 25)

The method of claim 25 further comprising providing chemotherapy to said patients.

### Claim 29 (depends on 27)

The method of claim 27 wherein the anti-mitotic agent is a taxane.

### Claim 30 (depends on 20)

The method of claim 20 wherein the anti-mitotic agent is a taxane.
