Claims for Patent: 10,047,398

Summary for Patent: 10,047,398

Title:	Method for the diagnosis, prognosis and treatment of breast cancer metastasis
Abstract:	The present invention relates to a method for the diagnosis or the prognosis of metastasis in breast cancer which comprises determining if the c-MAF gene is amplified in a primary tumor sample. Likewise, the invention also relates to a method for the diagnosis or the prognosis of metastasis in ER- breast cancer, as well as to a method for determining the tendency to develop bone metastasis with respect to metastasis in other organs, which comprise determining the c-MAF gene expression level. Finally, the invention relates to the use of a c-MAF inhibitor as therapeutic target for treating the ER- breast cancer metastasis.
Inventor(s):	Gomis; Roger (Barcelona, ES), Tarragona; Maria (Barcelona, ES), Arnal; Anna (Barcelona, ES), Pavlovic; Milica (Lajkovac, RS)
Assignee:	Fundacio Institut de Recerca Biomedica (IRB Barcelona) (Barcelona, ES) Institucio Catalana de Recerca I Estudis Avancats (Barcelona, ES)
Application Number:	13/878,114
Patent Claims:	1. An in vitro method for diagnosing the presence and/or risk of developing bone metastasis and/or bone metastasis recurrence in a human subject and for treating bone metastasis or bone metastasis recurrence, or the increased risk of developing bone metastasis and/or recurrence, wherein the human subject has ER+ breast cancer, comprising: (i) obtaining a breast tumor tissue sample from the human subject; (ii) detecting c-MAF gene amplification in the breast tumor tissue sample by performing a nucleic acid based detection assay on the tumor tissue sample; (iii) diagnosing the human subject as having bone metastasis and/or recurrence or at increased risk of developing bone metastasis and/or recurrence based on the detection of c-MAF gene amplification in the tumor tissue sample as compared to a control sample; and (iv) administering a therapeutically effective amount of a bisphosphonate or a RANKL inhibitor to the human subject diagnosed as having bone metastasis and/or recurrence or at increased risk of developing bone metastasis and/or recurrence to thereby treat bone metastasis or bone metastasis recurrence, or the increased risk of developing bone metastasis and/or recurrence. 2. The method according to claim 1, wherein the control sample is a tumor tissue sample of breast cancer from a subject who has not suffered metastasis. 3. The method according to claim 1, wherein detecting c-MAF gene amplification comprises performing in situ hybridization or polymerase chain reaction (PCR). 4. The method according to claim 1, wherein the bone metastasis is osteolytic metastasis. 5. The method according to claim 1, wherein the agent capable of avoiding or preventing bone degradation is a RANKL inhibitor. 6. The method according to claim 5, wherein the RANKL inhibitor is selected from the group consisting of a RANKL, specific antibody and osteoprotegerin. 7. The method according to claim 6, wherein the RANKL specific antibody is denosumab. 8. The method according to claim 1, wherein the bisphosphonate is zoledronic acid. 9. The method according to claim 1, wherein the c-MAF gene is amplified at least about 1.1 times, 1.5 times, 5 times, 10 times, 20 times, 30 times, 40 times, 50 times, 60 times, 70 times, 80 times, 90 times, 100 times or greater compared with the control sample. 10. The method according to claim 3, wherein the in situ hybridization is fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH) or silver in situ hybridization (SISH). 11. The method according to claim 10, wherein the in situ hybridization is fluorescence in situ hybridization (FISH). 12. The method according to claim 1, wherein detecting c-MAF gene amplification comprises using a c-MAF gene-specific probe and wherein the c-MAF gene-specific probe is a fluorescent probe. 13. The method according to claim 12, wherein the fluorescent probe is used in fluorescence in situ hybridization (FISH).

Details for Patent 10,047,398

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen Inc.	PROLIA	denosumab	Injection	125320	June 01, 2010		2030-10-06
Amgen Inc.	XGEVA	denosumab	Injection	125320	November 18, 2010		2030-10-06