# US 8,999,396 B2 · Breast cancer therapy based on hormone receptor status with nanoparticles comprising taxane > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,999,396 B2 - Document ID: US8999396B2 - Status: Granted - Kind: B2 - Application number: 13/779,624 - Filed: 2013-02-27 - Published: 2013-10-24 - Granted: 2015-04-07 - Earliest claimed: 2006-12-14 - Assignees: Abraxis BioScience, LLC - Applicants: Abraxis BioScience, LLC - Inventors: Neil P. Desai; Patrick Soon-Shiong - Web page: https://patentgrep.com/patent/US8999396B2 ## CPC - A61K 47/643: {Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]} - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/5169: {Proteins, e.g. albumin, gelatin} - A61K 31/282: Platinum compounds - A61K 31/337: having four-membered rings, e.g. taxol - A61K 31/475: having an indole ring, e.g. yohimbine, reserpine, strychnine, vinblastine (vincamine A61K31/4375) - A61K 31/505: Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim - A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine - A61K 31/5377: not condensed and containing further heterocyclic rings, e.g. timolol - A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos} - A61K 31/664: Amides of phosphorus acids - A61K 31/7034: attached to a carbocyclic compound, e.g. phloridzin - A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)} - A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid - A61K 39/39558: {against tumor tissues, cells, antigens} - A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34) - A61K 47/64: Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent (peptidic linkers A61K47/65) - A61P 35/00: Antineoplastic agents - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates to methods and kits for the treatment of breast cancer based on hormone receptor status of progesterone receptor and estrogen receptor comprising the administration of a taxane alone, in combination with at least one other and other therapeutic agents, as well as other treatment modalities useful in the treatment of breast cancer. In particular, the invention relates to the use of nanoparticles comprising paclitaxel and albumin (such as Abraxane®) either alone or in combination with other chemotherapeutic agents or radiation, which may be used for the treatment of breast cancer which does not express estrogen receptor and/or progesterone receptor. ## Claims ### Claim 1 A method for treating breast cancer in an individual, the method comprising: (a) determining hormone receptor status of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor-2; and (b) administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein the hormone receptor status of the individual is negative for estrogen receptor (ER−), progesterone receptor (PR−) and human epidermal growth factor receptor-2 (HER2−). ### Claim 2 A method for treating breast cancer in an individual, the method comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein negative hormone receptor status of estrogen receptor (ER−), progesterone receptor (PR−), and human epidermal growth factor receptor-2 (HER2−) is used as a basis for selecting the individual to receive treatment. ### Claim 3 A method of identifying an individual suitable for breast cancer treatment, the method comprising determining hormone receptor status of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor-2, wherein the individual is identified as suitable for breast cancer treatment with nanoparticles comprising a taxane and a carrier protein if hormone receptor status is negative for estrogen receptor (ER−), progesterone receptor (PR−), and human epidermal growth factor receptor-2 (HER2−). ### Claim 4 (depends on 2) The method of claim 2, wherein the taxane is paclitaxel. ### Claim 5 (depends on 2) The method of claim 2, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm. ### Claim 6 (depends on 2) The method of claim 2, wherein the carrier protein is albumin. ### Claim 7 (depends on 6) The method of claim 6, wherein the albumin is human serum albumin. ### Claim 8 (depends on 6) The method of claim 6, wherein the weight ratio of albumin and the paclitaxel in the nanoparticle composition is less than about 9:1. ### Claim 9 (depends on 4) The method of claim 4, wherein the nanoparticle composition is free of Cremophor. ### Claim 10 (depends on 2) The method of claim 2, further comprising administering to the individual an effective amount of at least one other chemotherapeutic agent. ### Claim 11 (depends on 10) The method of claim 10, wherein the at least one other chemotherapeutic agent comprises 5-fluorouracil, epirubicin, and cyclophosphamide. ### Claim 12 (depends on 11) The method of claim 11, wherein the breast cancer is locally advanced breast cancer. ### Claim 13 (depends on 2) The method of claim 2, wherein the individual is human.