Clinical trial NCT00077857: A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-02-16
Enrollment: 470
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
* previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.

Primary outcomes:
measure: Time to Progression of Disease or Death
timeFrame: Event driven (after 350 events). Median observation time was approximately 16 months.
Secondary outcomes:
measure: Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)
timeFrame: Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.
measure: Time to Overall Response
timeFrame: Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.
measure: Duration of Overall Response
timeFrame: Until PD or death. Median duration of response was approximately 7 months.
measure: Time to Treatment Failure
timeFrame: Until premature withdrawal or end of primary study treatment (up to 16 cycles).
measure: Overall Survival
timeFrame: Throughout the study. Median observation time was approximately 16 months.
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: First study drug intake until last study drug intake plus 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hoover
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Berkeley
country: United States
state: California
city: Poway
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Shores
country: United States
state: Florida
city: Port Saint Lucie
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Skokie
country: United States
state: Illinois
city: Urbana
country: United States
state: Illinois
city: Beech Grove
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Houma
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Jefferson City
country: United States
state: Missouri
city: St Joseph
country: United States
state: Missouri
city: Paramus
country: United States
state: New Jersey
city: Summit
country: United States
state: New Jersey
city: Williamsville
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Kingston
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Collierville
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Colchester
country: United States
state: Vermont
city: Abingdon
country: United States
state: Virginia
city: Walla Walla
country: United States
state: Washington
city: Mostar
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Tuzla
country: Bosnia and Herzegovina
city: Beijing
country: China
city: Beijing
country: China
city: Bengbu
country: China
city: Dalian
country: China
city: Dalian
country: China
city: Hangzhou
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Pardubice
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Tabor
country: Czech Republic
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Bangalore
country: India
city: Cochin
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Jaipur
country: India
city: Kolkata
country: India
city: Ludhiana
country: India
city: Manipal
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Trivandrum
country: India
city: Vellore
country: India
city: Poznan
country: Poland
city: Wroclaw
country: Poland
city: Chelyabinsk
country: Russian Federation
city: Ivanovo
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Omsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Samara
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Bloemfontein
country: South Africa
city: Durban
country: South Africa
city: Polokwane
country: South Africa
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: