The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both Alimta and Gemzar in patients with advanced breast cancer.

Condition	Treatment or Intervention	Phase
Breast Cancer	Drug: Pemetrexed (Alimta)-Investigational drug  Drug: Gemcitabine (Gemzar)	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).
• Less than 3 different chemotherapy types for metastatic disease.
• Prior treatment with hormonal and/or radiation therapy.
• Must have disease that can be measured.
• Must be able to take care of self needs for example personal hygiene

Exclusion Criteria:

• Must not be pregnant or breast-feeding.
• Cancer that has spread to the brain.
• Treatment with Gemcitabine(Gemzar) or Pemetrexed(Alimta)
• Unable to take folic acid or Vit B12
• Treatment for another cancer within the last 5 years

"There may be multiple sites in this clinical trial"      1-877-CTLILLY (1-877-285-4559) 

Colorado
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Aurora,  Colorado,  United States; Recruiting
Oklahoma
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Tulsa,  Oklahoma,  United States; Recruiting
Pennsylvania
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Philadelphia,  Pennsylvania,  United States; Recruiting
Texas
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Dallas,  Texas,  United States; Recruiting
Washington
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Seattle,  Washington,  United States; Recruiting

Study ID Numbers:  5141
Record last reviewed:  January 2005
Last Updated:  January 18, 2005
Record first received:  June 30, 2003
ClinicalTrials.gov Identifier:  NCT00063570
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08