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

This study has been terminated.
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: July 12, 2004
Last updated: December 15, 2005
Last verified: December 2005

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 Intervention Phase
Breast Cancer
Drug: XELODA [capecitabine]
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087620

  Show 35 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00087620     History of Changes
Other Study ID Numbers: ML17771
Study First Received: July 12, 2004
Last Updated: December 15, 2005
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014