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