Brooksville, Florida 34613

  • Breast Cancer


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).


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 is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

Overall Status:


Study Phase:

Phase 4



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Start Date:September 2004
Completion Date:October 2004
Completion Type:Actual
Primary Completion Date:October 2004
Primary Completion Type:Actual
Verification Date:February 2017
Last Changed Date:February 2, 2017
First Received Date:July 12, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:XELODA [capecitabine]

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: March 30, 2020

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