Patent ID: 9568476
Date: 2017-02-14
CPC Classifications: A61K,C12Q,G01N,G16H

Claim:
1. A method for determining a treatment course of action, comprising a) detecting the level of circulating tumor cells (CTC) in a sample from a subject with breast cancer using staining and an immunoassay; b) measuring the level of expression of estrogen receptor, HER-2, bcl-2, and ki67 on said CTC using a detection method selected from the group consisting of an immunoassay, nucleic acid amplification, and nucleic acid hybridization; c) calculating a numerical CTC-Endocrine Therapy Index (CTC-ETI) based on said number of CTC positive for expression of said estrogen receptor, HER-2, bcl-2, ki67, and total number of CTC, wherein said CTC-ETI is calculated by i) assigning zero points when the number of CTC is 0-4 per 7.5 ml, 1 point when the number of CTC is 5-10 per 7.5 ml, and 2 points when the number of CTC is greater than 10 per 7.5 ml; ii) assigning zero points when the number of CTC positive for estrogen receptor is greater than 10%, assigning 2 point when the number of CTC positive for estrogen receptor is 1-10%, and assigning 6 points when the number of CTC positive for estrogen receptor is zero; iii) assigning zero points when the number of CTC positive for HER-2 is 0%, assigning 1 point when the number of CTC positive for HER-2 is 1-10%, and assigning two points when the number of CTC positive for HER-2 is greater than 10%; iv) assigning zero points when the number of CTC positive for bcl-2 is greater than 10%, assigning 1 point when the number of CTC positive for bcl-2 is 1-10%, and assigning 2 points when the number of bcl-2 is 0%; v) assigning zero points when the number of CTC positive for ki67 is 0%, assigning 1 point when the number of CTC positive for Ki-67 is 1-10%, and assigning 2 points when the number of CTC positive for Ki-67 is greater than 10%; and vi) adding said points to obtain said CTC-ETI; and d) administering an anti-estrogen therapy selected from the group consisting of a selective estrogen receptor modulator (SERM) and an aromatase inhibitor when said CTC-ETI is between 0 and 6 and administering chemotherapy when said CTC-ETI is between 7 and 14.