US 12,460,265 B2
Post-treatment breast cancer prognosis
Dennis Sgroi, Cambridge, MA (US); Mark G. Erlander, Carlsbad, CA (US); Yi Zhang, San Diego, CA (US); and Catherine A. Schnabel, San Diego, CA (US)
Assigned to Biotheranostics, Inc., San Diego, CA (US); and The General Hospital Corporation, Boston, MA (US)
Filed by Biotheranostics, Inc., San Diego, CA (US); and The General Hospital Corporation, Boston, MA (US)
Filed on Jul. 27, 2021, as Appl. No. 17/386,380.
Application 17/386,380 is a continuation of application No. 15/298,128, filed on Oct. 19, 2016, granted, now 11,078,538.
Application 15/298,128 is a continuation of application No. 13/914,617, filed on Jun. 10, 2013, abandoned.
Application 13/914,617 is a continuation of application No. PCT/US2011/064290, filed on Dec. 9, 2011.
Claims priority of provisional application 61/421,627, filed on Dec. 9, 2010.
Prior Publication US 2021/0355550 A1, Nov. 18, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. C12Q 1/00 (2006.01); A61P 35/00 (2006.01); C12Q 1/6886 (2018.01)
CPC C12Q 1/6886 (2013.01) [C12Q 2600/106 (2013.01); C12Q 2600/118 (2013.01); C12Q 2600/158 (2013.01)] 11 Claims
 
1. A method of treating breast cancer in a subject who has undergone removal of hormone receptor positive (HR+) node-negative breast cancer and has been treated with a first endocrine therapy comprising a selective estrogen receptor modulator (SERM), a selective estrogen receptor down-regulator (SERD), or an aromatase inhibitor (AI), the method comprising:
preparing or having prepared cDNA from nucleic acids in a breast cancer sample from the subject,
measuring or having measured the subject's expression levels of HoxB13, IL17BR, Bub1B, CENPA, NEK2, RACGAP1, and RRM2 from the cDNA,
calculating or having calculated a ratio of the subject's expression levels of HoxB13:IL17BR (“H:I ratio”),
normalizing or having normalized the subject's expression levels of Bub1B, CENPA, NEK2, RACGAP1, and RRM2,
calculating or having calculated a Molecular Grade Index (“MGI”) for the subject comprising summing the subject's normalized expression levels of Bub1B, CENPA, NEK2, RACGAP1, and RRM2,
calculating or having calculated a breast cancer index (BCI) prognostic value for the subject by combining or having combined the subject's H:I ratio and MGI,
comparing or having compared the subject's BCI prognostic value to a cut-off value that is or has been determined by the BCI values for a dataset comprising HR+ node-negative breast cancer subjects that did not have cancer recurrence and HR+ node-negative breast cancer subjects that did have cancer recurrence; and
treating the subject with a second endocrine therapy if the subject's BCI prognostic value is above the cut-off value.