The purpose of this study is to compare the time to disease progression in women 60 years of age or older with metastatic breast cancer who are treated with DOXIL® or Xeloda®.

This is an open-label, randomized, multicenter study comparing DOXIL® with Xeloda® as first line chemotherapy of metastatic breast cancer in women 60 years and older. Overall response rates and survival rates will be compared between the two treatment groups. Safety and quality of life assessments will also be compared between the two treatment groups. The study hypothesis is that the study drug will yield comparable efficacy (time to disease progression) with an improved tolerability profile.

DOXIL® willl be administered intravenously at a dose of 40 mg/m2 every 28 days for up to one year. Xeloda® will be administered orally at a dose of 1000 mg/m2 BID for 14 consecutive days followed by a 7-day rest period; This cycle is repeated every 21 days for up to one year.

• Breast Neoplasms
• Cancer of Breast
• Breast Cancer
• Cancer of the Breast

Inclusion Criteria:

• Patient must have clinically or pathologically proven metastatic breast cancer
• Measurable or non-measurable disease
• ECOG performance status 0-2
• Adequate bone marrow (ANC >= 1500, Platelets >= 100,000, Hemoglobin >= 9 g), renal (CrCl >= 30 mL/min) and liver (bilirubin within normal limits and ALT and AST <= 2 times upper limit of normal) functions
• LVEF > 45% measured by MUGA scan or echocardiogram within 6 weeks of randomization

Exclusion Criteria:

• Prior chemotherapy for metastatic disease (hormonal or chemotherapy in adjuvant setting and hormonal therapy in metastatic setting is allowed)
• Prior treatment with Xeloda® or DOXIL® in the adjuvant setting (prior anthracyclines up to certain dose limit is allowed)
• Evidence of brain metastases unless previously treated and asymptomatic for 3 months or greater
• History of cardiac disease with NYHA Class II or greater or clincial evidence of congestive heart failure
• Anthracycline resistant disease (locally recurrent or metastatic disease while on adjuvant anthracycline therapy or relapse < 18 months after therapy completion)