Clinical trial NCT00081796: Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
Official title: A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Metastases
Keywords: Metastatic Breast Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-04-22
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

Detailed description: All patients in this trial will receive either the investigational drug or capecitabine, a chemotherapy drug that is already approved to treat your disease. These drugs prevent tumor cells from dividing, so they may stop growing or die. The investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks. Patients who receive capecitabine will receive this drug by mouth for 14 days, every 21 days.

Eligibility criteria: Eligibility Criteria

In order to be eligible for this trial you must:

* Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.
* Have received previous treatment with anthracyclines (e.g., adriamycin, Doxorubicin) and taxanes (e.g., paclitaxel, docetaxel, Taxol®, Taxotere®) for your breast cancer and your doctor has determined that these treatment are no longer of benefit to you.
* Be at least 18 years of age.
* Not be taking other treatments for your cancer at the time you enter this trial.
* Not be pregnant.

Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (e.g., lab tests, CT scans).

Primary outcomes:
measure: Time to tumor progression.
Secondary outcomes:
measure: Overall survival.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Burbank
country: United States
state: California
city: Concord
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Gilroy
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Monterey Park
country: United States
state: California
city: Northridge
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Pamona
country: United States
state: California
city: Pomona
country: United States
state: California
city: Porterville
country: United States
state: California
city: Redondo Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Soquel
country: United States
state: California
city: Vista
country: United States
state: California
city: New London
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Fort Lauderdale
country: United States
state: Florida
city: Ft Lauderdale
country: United States
state: Florida
city: Gainsville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Centralia
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Danville
country: United States
state: Kentucky
city: Hazard
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Southfield
country: United States
state: Michigan
city: St. Joseph
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Hackensack
country: United States
state: New Jersey
city: Nyack
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Cincinatti
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Worthington
country: United States
state: Ohio
city: Dunmore
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Kingston
country: United States
state: Pennsylvania
city: Kttaning
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: Abingdon
country: United States
state: Virginia
city: Arlington
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: Buenos Aires
country: Argentina
city: Capital Federal
country: Argentina
city: Santa Fe
country: Argentina
city: Melbourne
country: Australia
city: Perth
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Bludesch
country: Austria
city: Vienna
country: Austria
city: Sorocaba
country: Brazil
state: San Paulo
city: Sao Paolo
country: Brazil
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Levis
country: Canada
state: Quebec
city: Montreal
country: Canada
city: Ontario
country: Canada
city: Ottawa
country: Canada
city: Quebec
country: Canada
city: Santiago
country: Chile
facility: Las Condes
city: Santiago
country: Chile
city: Bogota
country: Colombia
city: Cali Valle
country: Colombia
city: Medellin
country: Colombia
city: Hradec Kralove
country: Czech Republic
city: Nora Ves Pod Plesi
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Kemi
country: Finland
city: Oulu
country: Finland
city: Besancon
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Paris
country: France
city: Saint Cloud
country: France
city: Saint Herblain
country: France
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Halle
country: Germany
city: Heidelberg
country: Germany
city: Kiel
country: Germany
city: Munchen Bayern
country: Germany
city: Munich
country: Germany
city: Oldenberg
country: Germany
city: Budapest
country: Hungary
city: Szeged
country: Hungary
city: Ashkelon
country: Israel
city: Beer-Sheva
country: Israel
city: Haifa
country: Israel
city: Tel Aviv
country: Israel
city: Tel HaShomer
country: Israel
city: Bologna
country: Italy
city: Cuneo
country: Italy
city: Largo Agostino Gemelli
country: Italy
city: Livorno
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Novara
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Sassari
country: Italy
city: Gyeonggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Mexico DF Distrio Federal
country: Mexico
city: Tuluea Estand de Mexico
country: Mexico
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Kracow
country: Poland
city: Warsaw
country: Poland
city: Beja
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Craiova
country: Romania
city: Maribor
country: Slovenia
city: Capetown
country: South Africa
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Parktown
country: South Africa
city: Pretoria
country: South Africa
city: Alicante
country: Spain
city: Jaen
country: Spain
city: Madrid
country: Spain
city: Navarra
country: Spain
city: Valencia
country: Spain
city: Taipai
country: Taiwan
city: Taoyuang
country: Taiwan
city: Cardiff
country: United Kingdom
state: Carduff
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Ipswich
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Surrey
country: United Kingdom
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: