A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.

Time frame: Event driven (after 350 events). Median observation time was approximately 16 months.

Population: Per protocol population included all participants who received at least one dose of study and who did not have any major protocol deviations.

Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.

Time frame: Until PD or death. Median duration of response was approximately 7 months.

Population: Intent to treat population included all randomized participants.

An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Additional information about Adverse Events can be found in the Adverse Event Section.

Time frame: First study drug intake until last study drug intake plus 28 days

Population: Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m\^2 actual received an initial dose that ranged from 480 to 984 mg/m\^2 so are included in the 825 mg/m\^2 arm for safety.

Overall Survival was measured as the time from the date of randomization to the date of death.

Time frame: Throughout the study. Median observation time was approximately 16 months.

Population: Intent to treat population included all randomized participants.

According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.

Time frame: Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.

Population: Intent to treat population included all randomized participants.

For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.

Time frame: Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.

Population: Intent to treat population included all randomized participants.

The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events: * adverse events * insufficient therapeutic response (disease progression) * death * failure to return * refusing treatment/being unwilling to cooperate * withdrawing consent.

Time frame: Until premature withdrawal or end of primary study treatment (up to 16 cycles).

Population: Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m\^2 actual received an initial dose that ranged from 480 to 984 mg/m\^2 so are included in the 825 mg/m\^2 arm for safety.