A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer

February 2, 2017 updated by: Hoffmann-La Roche
To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Deer Park, California, United States, 94576
      • Greenbrae, California, United States, 94904
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90057
      • Orange, California, United States, 92868
    • Colorado
      • Aurora, Colorado, United States, 80010
    • Florida
      • Boca Raton, Florida, United States, 33428
      • Boynton Beach, Florida, United States, 33435
      • Brooksville, Florida, United States, 34613
      • Hollywood, Florida, United States, 33021
      • New Port Richey, Florida, United States, 34652
    • Georgia
      • Augusta, Georgia, United States, 30901
      • Savannah, Georgia, United States, 31405
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Skokie, Illinois, United States, 60077
    • Iowa
      • Waterloo, Iowa, United States, 50702
    • Kansas
      • Lenexa, Kansas, United States, 66214
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
    • Maine
      • Scarborough, Maine, United States, 04074
    • Maryland
      • Baltimore, Maryland, United States, 21237
      • Prince Frederick, Maryland, United States, 20678
    • Michigan
      • Lansing, Michigan, United States, 48909
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Nevada
      • Reno, Nevada, United States, 89502
    • New York
      • Rochester, New York, United States, 14642
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Wilmington, North Carolina, United States, 28401
      • Winston-salem, North Carolina, United States, 27103
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • South Carolina
      • Florence, South Carolina, United States, 29506
    • Texas
      • Corpus Christi, Texas, United States, 78412
      • Richardson, Texas, United States, 75080
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
      • Racine, Wisconsin, United States, 53405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Have provided written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
  • Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama
  • Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70%
  • Have confirmed breast cancer with locally advanced and/or metastases
  • Have at least one site with defined tumor
  • Have met one of the study definitions of primary or nonprimary resistance to an anthracycline-containing therapy

Exclusion Criteria:

  • Pregnant/lactating women
  • Women of childbearing potential with either a positive or no pregnancy test
  • Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential)
  • Prior treatment with chemotherapy in the advanced/metastatic setting
  • HER 2/neu positive status without prior treatment with trastuzumab
  • Prior treatment with IV bolus 5-FU, continuous 5-FU infusion, capecitabine or other oral fluoropyrimidines
  • Prior treatment with a taxane if less than 12 months passed from the time of therapy completion to relapse
  • Mitomycin C or nitrosoureas within 6 weeks preceding treatment start
  • Organ allografts requiring immunosuppressive therapy
  • Radiotherapy to the skeleton within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiotherapy
  • Hormonal therapy within 10 days preceding study treatment start
  • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
  • Blood transfusions/growth factors to aid hematologic recovery within 2 weeks prior to study treatment start
  • Participation in any investigational drug study within 4 weeks preceding treatment start
  • Prior unanticipated severe reaction to fluoropyrimidine therapy
  • Known hypersensitivity to 5-fluorouracil, taxanes or any of the components of capecitabine
  • Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues
  • Evidence of CNS metastases
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma
  • Clinically significant (i.e. active) cardiac disease
  • Abnormal laboratory values
  • Severe renal impairment
  • Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
  • Lack of physical integrity of the upper GI tract
  • Life expectancy of less than 3 months
  • Unwilling/unable to comply with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2004

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

July 12, 2004

First Submitted That Met QC Criteria

July 13, 2004

First Posted (Estimate)

July 14, 2004

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML17771

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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