# US 2013/0280337 A1 · 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 2013/0280337 A1 - Document ID: US20130280337A1 - Status: Published application - Kind: A1 - Application number: 13/779,624 - Filed: 2013-02-27 - Published: 2013-10-24 - 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/US20130280337A1 ## 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 and/or progesterone receptor; and (b) administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein. ### 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 hormone receptor status of estrogen receptor and/or progesterone receptor 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 and/or progesterone receptor, 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 both estrogen receptor and progesterone receptor. ### Claim 4 A method of assessing responsiveness of an individual to a breast cancer therapy, the method comprising determining hormone receptor status of estrogen receptor and/or progesterone receptor, wherein the breast cancer therapy comprises administering a composition comprising nanoparticles comprising a taxane and a carrier protein and wherein (a) the individual is likely more responsive to the therapy if the hormone receptor status is negative for both estrogen receptor and progesterone receptor and (b) the individual is likely less responsive to the therapy if the hormone receptor status is positive for estrogen receptor and/or progesterone receptor. ### Claim 5 (depends on 2) The method of claim 2, wherein the hormone receptor status of the individual is negative for both estrogen receptor and progesterone receptor. ### Claim 6 (depends on 2) The method of claim 2, wherein the taxane is paclitaxel. ### Claim 7 (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 8 (depends on 2) The method of claim 2, wherein the carrier protein is albumin. ### Claim 9 (depends on 8) The method of claim 8, wherein the albumin is human serum albumin. ### Claim 10 (depends on 8) The method of claim 8, wherein the weight ratio of albumin and the paclitaxel in the nanoparticle composition is less than about 9:1. ### Claim 11 (depends on 6) The method of claim 6, wherein the nanoparticle composition is free of Cremophor. ### Claim 12 (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 13 (depends on 12) The method of claim 12, wherein the at least one other chemotherapeutic agent comprises 5-fluorouracil, epirubicin, and cyclosphosphamide. ### Claim 14 (depends on 13) The method of claim 13, wherein the breast cancer is locally advanced breast cancer. ### Claim 15 (depends on 14) The method of claim 14, wherein the breast cancer expresses HER2 (HER2+). ### Claim 16 (depends on 14) The method of claim 14, wherein the breast cancer does not express HER2 (HER2−). ### Claim 17 (depends on 2) The method of claim 2, wherein the individual is human. ### Claim 18 A kit comprising: (a) an agent for detecting hormone receptor status of estrogen receptor and/or progesterone receptor of a breast cancer patient; and (b) a composition comprising nanoparticles comprising a taxane and a carrier protein. ### Claim 19 A kit comprising: (a) an agent for detecting hormone receptor status of estrogen receptor and/or progesterone receptor of a breast cancer patient; and (b) instructions for assessing likely responsiveness to therapy for treating breast cancer based on hormone receptor status of estrogen receptor and/or progesterone receptor, wherein the therapy comprises administering a composition comprising nanoparticles comprising a taxane and a carrier protein. ### Claim 20 (canceled) ### Claim 21 (depends on 18) The kit of claim 18, wherein the taxane is paclitaxel. ### Claim 22 (canceled) ### Claim 23 (canceled) ### Claim 24 (depends on 18) The kit of claim 18, wherein the carrier protein is albumin. ### Claim at position 25 25-32. (canceled)