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Completed

NCT Number: NCT00077857

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mostar, Bosnia and Herzegovina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capecitabine (Xeloda®)

Drug

825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.

Other names: Xeloda®

Docetaxel (Taxotere®)

Drug

75 mg/m^2 intravenous on day 1 of each 3 week cycle

Other names: Taxotere®

Primary outcomes

  1. Time to Progression of Disease or Death

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

    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.

Secondary outcomes

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

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

    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.

  2. Time to Overall Response

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

    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.

  3. Duration of Overall Response

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

    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.

  4. Time to Treatment Failure

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

    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.

  5. Overall Survival

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

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

  6. Number of Participants With Adverse Events and Serious Adverse Events

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

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Feb 16, 2004
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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