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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077857
First received: February 12, 2004
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: capecitabine (Xeloda®)
Drug: docetaxel (Taxotere®)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to Progression of Disease or Death [ Time Frame: Event driven (after 350 events). Median observation time was approximately 16 months. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 to Overall Response [ Time Frame: Until PD or end of primary study treatment (up to 16 cycles) plus 28 days. ] [ Designated as safety issue: No ]
    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.

  • Duration of Overall Response [ Time Frame: Until PD or death. Median duration of response was approximately 7 months. ] [ Designated as safety issue: No ]
    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 to Treatment Failure [ Time Frame: Until premature withdrawal or end of primary study treatment (up to 16 cycles). ] [ Designated as safety issue: No ]

    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.

  • Overall Survival [ Time Frame: Throughout the study. Median observation time was approximately 16 months. ] [ Designated as safety issue: No ]
    Overall Survival was measured as the time from the date of randomization to the date of death.

  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: First study drug intake until last study drug intake plus 28 days ] [ Designated as safety issue: No ]

    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.



Enrollment: 470
Study Start Date: July 2003
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1250 mg/m^2 capecitabine + docetaxel
1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
 Drug: capecitabine (Xeloda®)
825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
Other Name: Xeloda®
Drug: docetaxel (Taxotere®)
75 mg/m^2 intravenous on day 1 of each 3 week cycle
Other Name: Taxotere®
Experimental: 825 mg/m^2 capecitabine + docetaxel
825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
 Drug: capecitabine (Xeloda®)
825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
Other Name: Xeloda®
Drug: docetaxel (Taxotere®)
75 mg/m^2 intravenous on day 1 of each 3 week cycle
Other Name: Taxotere®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077857

  Show 94 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077857     History of Changes
Obsolete Identifiers: NCT00083200
Other Study ID Numbers: NO16853
Study First Received: February 12, 2004
Results First Received: February 13, 2013
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013