Claims for Patent: 8,580,496

Summary for Patent: 8,580,496

Title:	Method and kit for the detection of genes associated with PIK3CA mutation and involved in PI3K/AKT pathway activation in the ER-postitive and HER2-positive subtypes with clinical implications
Abstract:	A method to determine the clinical outcome of breast tumor affecting a patient if treated with an antitumoral agent against breast tumor. The method includes the step of assaying a sample of a breast tumor from the patient for an expression level of selected genes, by contacting mRNA sequences from the cells of this breast tumor with a set of more than 3 nucleotide sequences related to human mutated PIK3CA.
Inventor(s):	Sotiriou; Christos (Uccle, BE), Loi; Sherene (Brussels, BE), McArthur; Grant (Camberwell, AU), Haibe-Kains; Benjamin (Brussels, BE)
Assignee:	Universite Libre de Bruxelles (Brussels, BE)
Application Number:	12/860,638
Patent Claims:	1. A method to determine a signature of PIK3CA for treatment of early stage breast cancer in a patient, the method comprising: measuring an expression level of genes from a biopsy of a breast cancer tumour from the patient by contacting mRNA sequences from the cells of the said biopsy with a gene set of at least 3 capture nucleotide sequences that specifically hybridizes to RNA encoded by ARHGDIB, GALNT2 and PFN2 of a breast cell; determining the PIK3CA signature for said tumour, wherein under-expression of ARHGDIB and GALNT2 and/or overexpression of PFN2 corresponds to a wild-type PIK3CA signature; and administering to a patient comprising a breast cancer tumour having a wild-type PIK3CA signature a PI3-kinase inhibitor or a PI3-kinase pathway inhibitor. 2. The method of claim 1, wherein the gene set further comprises one or more capture nucleotide sequences selected from the sequences of Table 6. 3. The method of claim 1 further comprising a step of sequencing of the PIK3CA gene. 4. The method of claim 1 further comprising a step of determining a clinical outcome of breast tumour affecting a patient if treated with an antitumoural agent against breast tumour. 5. The method according to claim 4 wherein the breast tumour is ER+. 6. The method according to the claim 5 wherein the breast tumour is obtained from a high proliferative tumour sample. 7. The method according to the claim 5 wherein the breast tumour is a luminal B ER+ tumour. 8. The method of claim 7, wherein the breast tumor harbours overexpression of ARHGDIB and GALNT2 and/or under-expression of PFN2 and which further comprises a step of administering to the patient, an anti-oestrogen agent selected from the group consisting of tamoxifen, raloxifene, faslodex and a mixture thereof. 9. The method according to claim 5, further comprising a step of administering to the patient an anti oestrogen agent selected from the group consisting of a selective oestrogen receptor modulator, a selective oestrogen receptor down regulator, a GnRH analog, and an aromatase inhibitor. 10. The method of claim 5, wherein the breast tumor harbours overexpression of ARHGDIB and GALNT2 and/or under-expression of PFN2 and which further comprises a step of administering to the patient an anti-oestrogen agent selected from the group consisting of tamoxifen, raloxifene, faslodex, and a mixture thereof. 11. The method according to claim 5, wherein the breast tumor harbours overexpression of ARHGDIB and GALNT2 and/or under-expression of PFN2 and wherein the breast tumor is Her2+, and which further comprises a step of administering to the patient an antitumoral agent selected from the group consisting of a selective oestrogen receptor modulator, a selective oestrogen receptor down regulator, a GnRH analog, and an aromatase inhibitor. 12. The method of claim 11 wherein the antitumoral agent further comprise an anti Her2 compound. 13. The method of claim 12, wherein the anti Her2 compound is an anti Her2 antibody. 14. The method of claim 13, wherein the anti Her2 compound is Trastuzumab. 15. The method of claim 1, wherein the inhibitor of the PI3-kinase pathway is a mTOR inhibitor. 16. The method of claim 15, wherein the mTOR inhibitor is Everolimus. 17. The method according to claim 4, wherein the breast tumor harbours overexpression of ARHGDIB and GALNT2 and/or under-expression of PFN2 and wherein the breast tumor is Her2+, and which further comprises a step of administering to the patient an antitumoral agent being an anti Her2 compound. 18. The method of claim 17, wherein the anti Her2 compound is an anti Her2 antibody. 19. The method of claim 18, wherein the anti Her2 antibody is Trastuzumab. 20. The method according to claim 5, wherein the breast tumor harbours a wild-type PIK3CA signature and which further comprises a step of administering to the patient a chemotherapy. 21. The method according to claim 5, wherein the breast tumor harbours a wild-type PIK3CA signature and which further comprises a step of administering to the patient a radiotherapy. 22. The method of claim 1, wherein the expression level of up to 81 genes is measured. 23. The method of claim 1, wherein the breast cancer tumor is less than 2 cm and/or the patient has a negative lymph node status.

Details for Patent 8,580,496

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2028-02-21
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2028-02-21
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2028-02-21