# US 2006/0154267 A1 · Diagnosis and treatment of breast cancer

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- Number: US 2006/0154267 A1
- Document ID: US20060154267A1
- Status: Published application
- Kind: A1
- Application number: 11/089,097
- Filed: 2005-03-24
- Published: 2006-07-13
- Earliest claimed: 2003-09-19
- Assignees: Arcturus Bioscience, Inc.
- Inventors: Xiao-Jun Ma; Mark Erlander; Dennis Sgroi; Edward Enright
- Web page: https://patentgrep.com/patent/US20060154267A1

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/30: for calculating health indices; for individual health risk assessment
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/154: Methylation markers
- 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
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Methods and compositions are provided for the identification of expression signatures in ER+ breast cancer cases, where the signatures correlate with responsiveness, or lack thereof, to treatment with tamoxifen or another antiestrogen agent against breast cancer The signature profiles are identified based upon sampling of reference breast tissue samples from independent cases of breast cancer and provide a reliable set of molecular criteria for predicting the efficacy of treating a subject with breast cancer with tamoxifen or another antiestrogen agent against breast cancer. Additional methods and compositions are provided for predicting responsiveness to tamoxifen or another antiestrogen agent against breast cancer in cases of breast cancer by use of multiple biomarkers. Two biomarkers display increased expression correlated with tamoxifen response while two other biomarkers display decreased expression correlated with tamoxifen response.

## Claims

### Claim 1

A method in the medical care of a patient, said method comprising measuring the expression of HOXB13, IL17BR, CHDH, and/or QPRT in a cell containing sample of said patient after determination of a need for to measure said expression; and optionally interpreting the results.

### Claim 2 (depends on 1)

A method in the processing of reimbursement or payment for a test, said method comprising indicating that 1) payment has been received, or 2) payment will be made by other payer, or 3) payment remains unpaid after performance of the method of claim 1.

### Claim 3 (depends on 1)

A method in the processing of reimbursement or payment for a test, said method comprising receiving reimbursement for the technical performance of the method of claim 1 or the interpretation of the results from said method.

### Claim 4 (depends on 1)

A method in the processing of reimbursement or payment for a test, said method comprising forwarding or having forwarded a reimbursement request to an insurance company, health maintenance organization, federal health agency, or to said patient for the performance of the method of claim 1.

### Claim 5 (depends on 1)

A method in the processing of reimbursement or payment for a test, said method comprising receiving indication of approval for payment or denial of payment for performance of the method of claim 1.

### Claim 6 (depends on 1)

A method in the processing of reimbursement or payment for a test, said method comprising sending a request for reimbursement for performance of the method of claim 1.

### Claim 7 (depends on 1)

A method in the processing of reimbursement or payment for a test, said method comprising indicating the need for reimbursement or payment on a form or into a database for performance of the method of claim 1.

### Claim 8 (depends on 1)

A method in the processing of reimbursement or payment for a test, said method comprising indicating the performance of the method of claim 1 on a form or into a database.

### Claim 9 (depends on 1)

A method in the medical care of a patient, said method comprising reporting the results of the method of claim 1, optionally to a health care facility, a health care provider, a doctor, a nurse, or said patient.

### Claim 10 (depends on 1)

A method in the medical care of a patient, said method comprising receiving a payment from said patient for the performance of the method of claim 1.