A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
1 other identifier
interventional
N/A
1 country
35
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2004
Shorter than P25 for phase_4 breast-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2004
CompletedFirst Posted
Study publicly available on registry
July 14, 2004
CompletedStudy Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFebruary 3, 2017
February 1, 2017
1 month
July 12, 2004
February 2, 2017
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Deer Park, California, 94576, United States
Unknown Facility
Greenbrae, California, 94904, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Aurora, Colorado, 80010, United States
Unknown Facility
Boca Raton, Florida, 33428, United States
Unknown Facility
Boynton Beach, Florida, 33435, United States
Unknown Facility
Brooksville, Florida, 34613, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
New Port Richey, Florida, 34652, United States
Unknown Facility
Augusta, Georgia, 30901, United States
Unknown Facility
Savannah, Georgia, 31405, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Skokie, Illinois, 60077, United States
Unknown Facility
Waterloo, Iowa, 50702, United States
Unknown Facility
Lenexa, Kansas, 66214, United States
Unknown Facility
Lafayette, Louisiana, 70503, United States
Unknown Facility
Scarborough, Maine, 04074, United States
Unknown Facility
Baltimore, Maryland, 21237, United States
Unknown Facility
Prince Frederick, Maryland, 20678, United States
Unknown Facility
Lansing, Michigan, 48909, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Reno, Nevada, 89502, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Florence, South Carolina, 29506, United States
Unknown Facility
Corpus Christi, Texas, 78412, United States
Unknown Facility
Richardson, Texas, 75080, United States
Unknown Facility
Milwaukee, Wisconsin, 53215, United States
Unknown Facility
Racine, Wisconsin, 53405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2004
First Posted
July 14, 2004
Study Start
September 1, 2004
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
February 3, 2017
Record last verified: 2017-02