Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Inclusion Criteria:

• Must have been diagnosed with either advanced or metastatic breast cancer.
• Chemotherapy has not been given for advanced or metastatic breast cancer.
• The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
• Able to carry out work of a light nature (for example, light housework, office work).
• Must be at least 18 years old.

Exclusion Criteria:

• Have received prior bone marrow or peripheral stem cell transplantation.
• Have received prior chemotherapy for metastatic breast cancer.
• Are currently pregnant or breast-feeding.
• Have an active infection that your doctor decides will affect your safety.
• Are unable to take folic acid or vitamin B12.