Antineoplastic Combinations with m-TOR Inhibitor, Trastuzumab and/or HKI-272

Abstract

A combination of temsirolimus and trastuzumab in the treatment of cancer is provided. A combination of temsirolimus and HKI-272 is provided. A combination of a trastuzumab and a HKI-272 is also provided. Regimens and kits for treatment of metastatic breast cancer, containing trastuzumab, temsirolimus and/or HKI-272, optionally in combination with other anti-neoplastic agents, or immune modulators are described.

1 . A method of treating a neoplasm associated with overexpression or amplification of HER2 in a mammal in need thereof, which comprises providing to said mammal an effective amount of a combination of active components comprising a trastuzumab and a (E)-N-{4-[3-chloro-4-(2-pyridinyl methoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide (HKI-272). 
     
     
         2 - 19 . (canceled) 
     
     
         20 . A pharmaceutical pack containing a course of an anti-neoplastic treatment for one individual mammal, wherein the pack contains (a) at least one unit of a trastuzumab and (b) at least one unit of a (E)-N-{4-[3-chloro-4-(2-pyridinyl methoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide (HKI-272) in unit dosage form. 
     
     
         21 . A pharmaceutical composition useful in treating a neoplasm in a mammal, the composition comprising (a) at least one unit of a trastuzumab and (b) at least one unit of a (E)-N-{4-[3-chloro-4-(2-pyridinyl methoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide (HKI-272), in unit dosage form, and at least one pharmaceutically acceptable carrier.