Claims for Patent: 9,066,963

Summary for Patent: 9,066,963

Title:	Methods of treating breast cancer with anthracycline therapy
Abstract:	The application describes methods for screening subjects with breast cancer to determine if the breast cancer will be responsive to a breast cancer therapy including an anthracycline. The application also describes methods for treating subjects with breast cancer by screening them for the likelihood of the effectiveness of treating the cancer with a therapy including anthracycline and administering the therapy in subjects when it is found that anthracycline is likely to be effective.
Inventor(s):	Perou; Charles M. (Carrboro, NC), Ellis; Matthew J. (St. Louis, MO), Bernard; Philip S. (Salt Lake City, UT), Nielsen; Torsten O. (North Vancouver, CA)
Assignee:	The University of North Carolina at Chapel Hill (Chapel Hill, NC) Washington University (St. Louis, MO) University of Utah Research Foundation (Salt Lake City, UT) British Columbia Cancer Agency Branch (Vancouver, British Columbia, CA)
Application Number:	13/421,367
Patent Claims:	1. A method of treating breast cancer in a subject in need thereof comprising: (a) providing a biological sample from the subject; (b) assaying the biological sample to determine whether the biological sample is classified as a Her2+ subtype; (c) assaying the biological sample to determine whether the biological sample is classified as a Her-2-E subtype; (d) providing an assessment of the likelihood of effectiveness of a breast cancer treatment comprising an anthracycline in the subject, wherein if the biological sample is classified as both a Her2+ subtype and a Her-2-E subtype, the breast cancer treatment comprising the anthracycline is more likely to be effective in the subject and wherein if the biological sample is classified as a Her-2-E subtype and is classified as not a Her2+ subtype, the breast cancer treatment comprising the anthracycline is less likely to be effective in the subject; and (e) administering a breast cancer treatment comprising anthracycline to the subject subsequent to said assessment if the biological sample is classified as both a Her2+ subtype and a Her-2-E subtype and administering a breast cancer treatment not comprising anthracycline to the subject subsequent to said assessment if the biological sample is classified as a Her-2-E subtype and classified as not a Her2+ subtype, thereby treating breast cancer in the subject. 2. The method of claim 1, wherein assaying the biological sample to determine whether the biological sample is classified as a Her2+ subtype is performed using fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC). 3. The method of claim 1, wherein assaying the biological sample to determine whether the biological sample is classified as a Her-2-E subtype is performed by detecting the expression levels of a combination of at least 40 genes selected from Table 1, wherein at least 25 of the at least 40 genes comprise FOXA1, MLPH, ESR1, FOXC1, CDC20, ANLN, MAPT, ORC6L, CEP55, MKI67, UBE2C, KNTC2, EXO1, PTTG1, MELK, BIRC5, GPR160, RRM2, SRFP1, MYBL2, NAT1, KIF2C, CXXC5, MIA and BCL2. 4. The method of claim 1, wherein the anthracycline is selected from the group consisting of daunorubicin, doxorubicin, epirubicin, idarubicin, valrubicin and mitoxantrone. 5. The method of claim 4, wherein the anthracycline is epirubicin. 6. The method of claim 1, wherein the breast cancer treatment comprising anthracycline further comprises one or more anti-cancer agents selected from the group consisting of cyclophosphamide, fluorouracil (or 5-fluorouracil or 5-FU), methotrexate, thiotepa, carboplatin, cisplatin, taxanes, paclitaxel, protein-bound paclitaxel, docetaxel, vinorelbine, tamoxifen, raloxifene, toremifene, fulvestrant, gemcitabine, irinotecan, ixabepilone, temozolmide, topotecan, vincristine, vinblastine, eribulin, mutamycin, capecitabine, capecitabine, anastrozole, exemestane, letrozole, leuprolide, abarelix, buserlin, goserelin, megestrol acetate, risedronate, pamidronate, ibandronate, alendronate, denosumab, zoledronate, trastuzumab, tykerb or bevacizumab, or combinations thereof. 7. The method of claim 1, wherein the breast cancer treatment comprising anthracycline further comprises one or more anti-cancer agents selected from the group consisting of cyclophosphamide and 5-fluorouracil. 8. The method of claim 1, wherein the breast cancer treatment not comprising anthracycline further comprises one or more anti-cancer agents selected from the group consisting of cyclophosphamide, fluorouracil (or 5-fluorouracil or 5-FU), methotrexate, thiotepa, carboplatin, cisplatin, taxanes, paclitaxel, protein-bound paclitaxel, docetaxel, vinorelbine, tamoxifen, raloxifene, toremifene, fulvestrant, gemcitabine, irinotecan, ixabepilone, temozolmide, topotecan, vincristine, vinblastine, eribulin, mutamycin, capecitabine, capecitabine, anastrozole, exemestane, letrozole, leuprolide, abarelix, buserlin, goserelin, megestrol acetate, risedronate, pamidronate, ibandronate, alendronate, denosumab, zoledronate, trastuzumab, tykerb or bevacizumab, or combinations thereof. 9. The method of claim 1, wherein the breast cancer treatment not comprising an anthracycline comprises one or more anti-cancer agents of the group consisting of cyclophosphamide, 5-fluorouracil and methotrexate. 10. The method of claim 1, wherein the biological sample is selected from the group consisting of a cell, tissue and bodily fluid. 11. The method of claim 10, wherein the tissue is obtained from a biopsy. 12. The method of claim 10, wherein the bodily fluid is selected from the group consisting of blood, lymph, urine, saliva and nipple aspirate.

Details for Patent 9,066,963

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2031-03-15
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2031-03-15
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2031-03-15
Amgen, Inc.	PROLIA	denosumab	Injection	125320	06/01/2010		2031-03-15