US 11,676,731 B2
Diagnostic and therapeutic methods for the treatment of breast cancer
Anneleen Daemen, South San Francisco, CA (US); and Ciara Metcalfe, South San Francisco, CA (US)
Assigned to Genentech, Inc., South San Francisco, CA (US)
Filed by Genentech, Inc., South San Francisco, CA (US)
Filed on Jun. 25, 2021, as Appl. No. 17/359,186.
Application 17/359,186 is a continuation of application No. 16/542,817, filed on Aug. 16, 2019, granted, now 11,081,236.
Claims priority of provisional application 62/719,545, filed on Aug. 17, 2018.
Prior Publication US 2022/0044819 A1, Feb. 10, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 50/30 (2018.01); G16H 50/20 (2018.01); G16H 80/00 (2018.01); G01N 33/574 (2006.01)
CPC G16H 50/30 (2018.01) [G01N 33/57415 (2013.01); G16H 50/20 (2018.01); G16H 80/00 (2018.01)] 22 Claims
OG exemplary drawing
 
1. A method of treating breast cancer in an individual in need thereof, the method comprising:
(i) determining an estrogen receptor (ER) pathway activity score from a sample from the individual, wherein the ER pathway activity score from the sample is at or above a reference ER pathway activity score;
wherein the ER pathway activity score is calculated by subtracting an E2-repressed score, determined from the average z-scored expression of at least 4 of the E2-repressed genes selected from the group consisting of BAMBI, BCAS1, CCNG2, DDIT4, EGLN3, FAM171B, GRM4, IL1R1, LIPH, NBEA, PNPLA7, PSCA, SEMA3E, SSPO, STON1, TGFB3, TP53INP1, and TP53INP2, from an E2-induced score, determined from the average z-scored expression of 23 of the E2-induced genes selected from the group consisting of AGR3, AMZ1, AREG, C5AR2, CELSR2, CT62, FKBP4, FMN1, GREB1, IGFBP4, NOS1AP, NXPH3, OLFM1, PGR, PPM1J, RAPGEFL1, RBM24, RERG, RET, SGK3, SLC9A3R1, TFF1, and ZNF703; and
(ii) administering to the individual an effective amount of an endocrine therapy selected from the group consisting of:
(a) a selective estrogen receptor degrader, a selective estrogen receptor modulator, a selective estrogen receptor covalent antagonist, a selective human estrogen receptor agonist, an aromatase inhibitor, or a combination of two or more thereof;
(b) letrozole, anastrozole, exemestane, testolactone, hydroxytamoxifen, clomifene, toremifene, raloxifene, anordrin, bazedoxifene, broparestrol, cyclofenil, lasofoxifene, ormeloxifene, acolbifene, elacestrant, brilanestrant, clomifenoxide, droloxifene, etacstil, ospemifene, G1T48, AZ9496, GDC-0927, LX-039, fulvestrant, or GDC-9545, a pharmaceutically acceptable salt of one of the foregoing, or a combination of two or more of the foregoing; and
(c) a compound having formula:

OG Complex Work Unit Chemistry
 or a pharmaceutically acceptable salt thereof.