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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00087620
Recruitment Status : Terminated
First Posted : July 14, 2004
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: XELODA [capecitabine] Phase 4

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Actual Study Start Date : September 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00087620

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Sponsors and Collaborators
Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00087620     History of Changes
Other Study ID Numbers: ML17771
First Posted: July 14, 2004    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents