Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

Inclusion Criteria:

• Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
• No prior chemotherapy for locally advanced or metastatic breast disease.
• Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
• Adequate bone marrow, liver and kidney function
• RECIST criteria for disease status

Exclusion Criteria:

• Prior treatment with pemetrexed
• Pregnant or breast feeding
• Brain Metastasis
• unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.