A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
1 other identifier
interventional
470
9 countries
94
Brief Summary
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\^2 or 825 mg/m\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jul 2003
Longer than P75 for phase_2 breast-cancer
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 12, 2004
CompletedFirst Posted
Study publicly available on registry
February 16, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
May 10, 2013
CompletedMay 10, 2013
March 1, 2013
6.7 years
February 12, 2004
February 13, 2013
March 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Progression of Disease or Death
Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.
Event driven (after 350 events). Median observation time was approximately 16 months.
Secondary Outcomes (6)
Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)
Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.
Time to Overall Response
Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.
Duration of Overall Response
Until PD or death. Median duration of response was approximately 7 months.
Time to Treatment Failure
Until premature withdrawal or end of primary study treatment (up to 16 cycles).
Overall Survival
Throughout the study. Median observation time was approximately 16 months.
- +1 more secondary outcomes
Study Arms (2)
1250 mg/m^2 capecitabine + docetaxel
EXPERIMENTAL1250 mg/m\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\^2 intravenous on day 1 of each 3 week cycle.
825 mg/m^2 capecitabine + docetaxel
EXPERIMENTAL825 mg/m\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\^2 intravenous on day 1 of each 3 week cycle.
Interventions
825 mg/m\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
75 mg/m\^2 intravenous on day 1 of each 3 week cycle
Eligibility Criteria
You may qualify if:
- women \>=18 years of age;
- \>=1 target lesion;
- locally advanced or metastatic breast cancer;
- demonstrated resistance to anthracycline;
- \>=2 regimens of chemotherapy for advanced/metastatic disease.
You may not qualify if:
- previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
- previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Unknown Facility
Birmingham, Alabama, 35233, United States
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Hoover, Alabama, 35216, United States
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Tucson, Arizona, 85715, United States
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Berkeley, California, 94704, United States
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Poway, California, 92064, United States
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Boca Raton, Florida, 33486, United States
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Fort Lauderdale, Florida, 33308, United States
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Inverness, Florida, 34452, United States
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Jacksonville, Florida, 32207, United States
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Miami Shores, Florida, 33179, United States
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Port Saint Lucie, Florida, 34952, United States
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Tamarac, Florida, 33321, United States
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Skokie, Illinois, 60076, United States
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Urbana, Illinois, 61801, United States
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Beech Grove, Indiana, 46107, United States
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Des Moines, Iowa, 50314, United States
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Overland Park, Kansas, 66210, United States
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Houma, Louisiana, 70360, United States
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Baltimore, Maryland, 21202, United States
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Baltimore, Maryland, 21236, United States
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Frederick, Maryland, 21701, United States
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Rockville, Maryland, 20850-3348, United States
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Boston, Massachusetts, 02118, United States
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Detroit, Michigan, 48202-2689, United States
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Kalamazoo, Michigan, 49007, United States
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Jefferson City, Missouri, 65109, United States
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Saint Joseph, Missouri, 64507, United States
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Paramus, New Jersey, 07652, United States
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Summit, New Jersey, 07901, United States
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Williamsville, New York, 14221, United States
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Canton, Ohio, 44718, United States
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Mayfield Heights, Ohio, 44124, United States
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Allentown, Pennsylvania, 18104, United States
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Kingston, Pennsylvania, 18704, United States
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Charleston, South Carolina, 29406, United States
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Columbia, South Carolina, 29203, United States
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Collierville, Tennessee, 38017, United States
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Knoxville, Tennessee, 37920, United States
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Austin, Texas, 78705, United States
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Houston, Texas, 77030, United States
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Colchester, Vermont, 05446, United States
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Abingdon, Virginia, 24211, United States
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Walla Walla, Washington, 99362, United States
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Mostar, 88000, Bosnia and Herzegovina
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Sarajevo, 71000, Bosnia and Herzegovina
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Tuzla, 75000, Bosnia and Herzegovina
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Beijing, 100021, China
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Beijing, 100853, China
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Bengbu, 233004, China
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Dalian, 116011, China
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Dalian, 116027, China
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Hangzhou, 310009, China
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Shanghai, 200032, China
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Tianjin, 300060, China
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Pardubice, 532 03, Czechia
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Prague, 140 59, Czechia
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Prague, 150 06, Czechia
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Prague, 180 00, Czechia
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Tábor, 390 03, Czechia
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Ahmedabad, 380 016, India
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Bangalore, 560 078, India
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Bangalore, 560027, India
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Hyderabad, 500 033, India
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Hyderabad, 500 034, India
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Hyderabad, 500 082, India
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Jaipur, 302013, India
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Kochi, 682 026, India
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Kolkata, 700 053, India
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Ludhiana, 141 001, India
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Manipal, 576 104, India
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Mumbai, 400012, India
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New Delhi, 110085, India
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Trivandrum, 695 011, India
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Vellore, 632 004, India
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Poznan, 61-878, Poland
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Wroclaw, 50-981, Poland
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Chelyabinsk, 454087, Russia
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Ivanovo, 153040, Russia
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Kazan', 420029, Russia
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Kazan', 420111, Russia
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Moscow, 109033, Russia
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Moscow, 115478, Russia
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Omsk, 644013, Russia
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Ryazan, 390046, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Samara, 443031, Russia
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Yaroslavl, 150054, Russia
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Bloemfontein, 9301, South Africa
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Durban, 4001, South Africa
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Polokwane, 0699, South Africa
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2004
First Posted
February 16, 2004
Study Start
July 1, 2003
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
May 10, 2013
Results First Posted
May 10, 2013
Record last verified: 2013-03