A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria:

- Diagnosis of locally advanced or metastatic breast cancer not amenable to local
treatment.

- Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.

- Patients must have at least one measurable lesion in an area not previously
irradiated.

- No chemotherapy at least 4 weeks prior to study enrollment.

- Signed informed consent from patient.

Exclusion Criteria:

- Treatment with any drug within the last 30 days that has not received regulatory
approval.

- Serious systemic disorders, including active infection.

- Significant cardiovascular disease.

- Pregnancy or breast feeding.

- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.