Breast cancer therapy based on hormone receptor status with nanoparticles comprising taxane

Patent metadata

Field	Value
Publication number	US-9675578-B2
Application number	US-51912607-A
Country	US
Kind code	B2
Filing date	Dec 14, 2007
Priority date	Dec 14, 2006
Publication date	Jun 13, 2017
Grant date	Jun 13, 2017

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.

First claim

What is claimed is:

1. A method for treating breast cancer in an individual, the method comprising:
(a) determining hormone receptor status of estrogen receptor and progesterone receptor;
(b) administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel and an albumin, and
(c) administering to the individual an effective amount of 5-fluorouracil, epirubicin and cyclophosphamide (FEC),

wherein the hormone receptor status of the individual is negative for both estrogen receptor and progesterone receptor.

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 paclitaxel and an albumin and an effective amount of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), wherein negative hormone receptor status of estrogen receptor and progesterone receptor is used as a basis for selecting the individual to receive treatment.

3. The method of claim 2 , wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

4. The method of claim 2 , wherein the albumin is human serum albumin.

5. The method of claim 2 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1 or less.

6. The method of claim 2 , wherein the nanoparticle composition is free of Cremophor.

7. The method of claim 2 , wherein the breast cancer is locally advanced breast cancer.

8. The method of claim 7 , wherein the breast cancer expresses HER2 (HER2+).

9. The method of claim 2 , wherein the individual is human.

10. The method of claim 1 , wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

11. The method of claim 1 , wherein the albumin is human serum albumin.

12. The method of claim 1 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1 or less.

13. The method of claim 1 , wherein the individual is human.

14. The method of claim 1 , wherein the hormone receptor status of estrogen receptor and progesterone receptor is determined by immunohistochemistry.

15. The method of claim 2 , wherein the hormone receptor status of estrogen receptor and progesterone receptor is determined by immunohistochemistry.

16. The method of claim 1 , wherein the dosage of paclitaxel in the nanoparticle composition is 50-300 mg/m 2 .

17. The method of claim 2 , wherein the dosage of paclitaxel in the nanoparticle composition is 50-300 mg/m 2 .

18. The method of claim 1 , wherein the nanoparticle composition is free of Cremophor.

19. The method of claim 1 , wherein the breast cancer is locally advanced breast cancer.

20. The method of claim 1 , wherein the breast cancer expresses HER2 (HER2+).

21. The method of claim 1 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

22. The method of claim 2 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

23. The method of claim 1 , wherein the average diameter of the nanoparticles in the composition is no greater than about 150 nm.

24. The method of claim 2 , wherein the average diameter of the nanoparticles in the composition is no greater than about 150 nm.

25. The method of claim 1 , wherein the average diameter of the nanoparticles in the composition is about 130 nm.

26. The method of claim 2 , wherein the average diameter of the nanoparticles in the composition is about 130 nm.

27. The method of claim 3 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

28. The method of claim 10 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

29. The method of claim 23 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

30. The method of claim 24 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

31. The method of claim 25 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

32. The method of claim 26 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1, wherein the paclitaxel is coated with albumin.

33. The method of claim 1 , wherein the method is for treatment of breast cancer in a neoadjuvant setting.

34. The method of claim 2 , wherein the method is for treatment of breast cancer in a neoadjuvant setting.

35. The method of claim 16 , wherein the dosage of paclitaxel in the nanoparticle composition is 125 mg/m 2 .

36. The method of claim 17 , wherein the dosage of paclitaxel in the nanoparticle composition is 125 mg/m 2 .

37. The method of claim 1 , wherein the paclitaxel is coated with albumin.

38. The method of claim 2 , wherein the paclitaxel is coated with albumin.

Assignees

• Desai Neil P
• Soon-Shiong Patrick
• Abraxis Bioscience Llc

Inventors

• Desai Neil P
• Soon-Shiong Patrick

Classifications

• A61K47/64

  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) · CPC title

• A61K47/643 Primary

  Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL] · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K31/337 Primary

  having four-membered rings, e.g. taxol · CPC title

• A61K31/513

  having oxo groups directly attached to the heterocyclic ring, e.g. cytosine · CPC title