# US 10,501,800 B2 · Breast cancer prognosis

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- Number: US 10,501,800 B2
- Document ID: US10501800B2
- Status: Granted
- Kind: B2
- Application number: 13/843,482
- Filed: 2013-03-15
- Published: 2013-11-28
- Granted: 2019-12-10
- Earliest claimed: 2012-04-27
- Assignees: Regents of the University of Minnesota
- Applicants: Regents of the University of Minnesota
- Inventors: Carol Ann Lange; Todd Philip Knutson; Jason Basil Nikas
- Web page: https://patentgrep.com/patent/US10501800B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61P 5/32: Antioestrogens
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- 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
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides gene expression profiles indicative of whether a patient afflicted with PR driven malignancies is likely to be responsive to treatment with a therapeutic compound that is an anti-progestin. By identifying such responsiveness, a treatment provider may determine in advance those patients who would benefit from such treatment, as well as identify alternative therapies for non-responders. Also, provided are methods of using gene expression profiles and assays for identifying the presence of a gene expression profile in a patient.

## Claims

### Claim 1

A method of treating breast, ovarian, endometrial or uterine cancer in a patient, said method comprising:
a) obtaining a breast, ovarian, endometrial or uterine cancer sample from said patient;
b) detecting whether expression of THY1, KLF9, SPINK5L3, PHLDA1, MAP1A, SPRYD5, ATG12, PDK4, MSX2, TUBA3E, TSC22D1, TUBA3D, KHDRBS3, UTS2D, SLC35C1 and KIAA0513 is increased in said cancer sample as compared to a control;
c) diagnosing said patient with breast, ovarian, endometrial or uterine cancer amenable to treatment with an anti-progestin, alone or in combination with other treatment when the expression of THY1, KLF9, SPINK5L3, PHLDA1, MAP1A, SPRYD5, ATG12, PDK4, MSX2, TUBA3E, TSC22D1, TUBA3D, KHDRBS3, UTS2D, SLC35C1 and KIAA0513 is increased in said cancer sample as compared to a control; and
d) administering an effective amount of an anti-progestin to said patient with increased expression of THYL1, KLF9, SPINK5L3, PHLDA1, MAP1A, SPRYD5, ATG12, PDK4, MSX2, TUBA3E, TSC22D1, TUBA3D, KHDRBS3, UTS2D, SLC35C1 and KIAA0513.

### Claim 2

A method of treating breast, ovarian, endometrial or uterine cancer in a patient, said method comprising:
a) obtaining a breast, ovarian, endometrial or uterine cancer sample from said patient;
b) detecting whether expression of THY1, KLF9, SPINK5L3, PHLDA1, MAP1A, SPRYD5, ATG12, PDK4, MSX2, TUBA3E, TSC22D1, TUBA3D, KHDRBS3, UTS2D, SLC35C1 and KIAA0513 is increased in said cancer sample as compared to a control, wherein detection of increased expression is carried out with the use of radiolabeled probes for THY1, KLF9, SPINK5L3, PHLDA1,MAP1A, SPRYD5, ATG12, PDK4, MSX2, TUBA3E, TSC22D1, TUBA3D, KHDRBS3, UTS2D, SLC35C1 and KIAA0513, wherein said probes comprise SEQ ID NOs: 16-31;
c) diagnosing said patient with breast, ovarian, endometrial or uterine cancer amenable to treatment with an anti-progestin, alone or in combination with other treatment when the expression of THY1, KLF9, SPINK5L3, PHLDA1, MAP1A, SPRYD5, ATG12, PDK4, MSX2, TUBA3E, TSC22D1, TUBA3D, KHDRBS3, UTS2D, SLC35C1 and KIAA0513 is increased in said cancer sample as compared to a control; and
d) administering an effective amount of an anti-progestin-to said patient with increased expression of THY1, KLF9, SPINK5L3, PHLDA1, MAP1A, SPRYD5, ATG12, PDK4, MSX2, TUBA3E, TSC22D1, TUBA3D, KHDRBS3, UTS2D, SLC35C1 and KIAA0513.