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

Hoffmann-La Roche470 enrolled

Overview

This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\^2 or 825 mg/m\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

470

Conditions

Breast Cancer

Interventions

capecitabine (Xeloda®)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * women \>=18 years of age; * \>=1 target lesion; * locally advanced or metastatic breast cancer; * demonstrated resistance to anthracycline; * \>=2 regimens of chemotherapy for advanced/metastatic disease. Exclusion Criteria: * previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines; * previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.

Locations (94)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Hoover, Alabama, United States

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Berkeley, California, United States

Unnamed facility

Poway, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Time to Progression of Disease or Death

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.

Secondary Outcomes

Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)

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.

Time to Overall Response

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.

Duration of Overall Response

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.

Time to Treatment Failure

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).

Overall Survival

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.

Number of Participants With Adverse Events and Serious Adverse Events

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