Clinical trial NCT00435409: A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
Official title: A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.


Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
* Previous treatment with an anthracycline and a taxane in any setting
* Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Exclusion Criteria:

* History of inflammatory carcinoma if there is no other measurable disease
* More than 2 chemotherapy agents in the advanced disease setting
* Brain metastases

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline until disease progression (up to 3 years from first dose)
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline until response or disease progression (up to 3 years from first dose)
measure: Duration of Response (DR)
timeFrame: Baseline until response or disease progression (up to 3 years from first dose)
measure: Overall Survival (OS)
timeFrame: Baseline until death or up to 3 years from first dose
measure: Percent Chance of Participant Survival
timeFrame: Year 1, Year 2, Year 3
measure: Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Day 1 of each treatment cycle (up to 3 years or end of treatment)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)
timeFrame: Day 1 of each treatment cycle (up to 3 years or end of treatment)
measure: Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)
timeFrame: Day 1 of each treatment cycle (up to 3 years or end of treatment)
Other outcomes:
Locations:
city: Downey
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Montebello
country: United States
facility: Pfizer Investigational Site
state: California
city: Whittier
country: United States
facility: Pfizer Investigational Site
state: California
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boynton Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Coral Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Duluth
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Snellville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Avon
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Mooresville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Gretna
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Kensington
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Corinth
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Clairton
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greensburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pottstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wexford
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Gallatin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Georgetown
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bountiful
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Layton
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Murray
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Provo
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Valley City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Kennewick
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Linz
country: Austria
facility: Pfizer Investigational Site
city: Salzburg
country: Austria
facility: Pfizer Investigational Site
city: Wels
country: Austria
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Namur
country: Belgium
facility: Pfizer Investigational Site
city: Turnhout
country: Belgium
facility: Pfizer Investigational Site
city: Yvoir
country: Belgium
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Praha 4
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Koebenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Odense
country: Denmark
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
state: Cedex 05
city: Angers cedex 01
country: France
facility: Pfizer Investigational Site
city: BORDEAUX Cedex
country: France
facility: Pfizer Investigational Site
city: CAEN Cedex 5
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Frankenthal
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Fuerstenwalde
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Stendal
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Voelklingen
country: Germany
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
city: Patras
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Parma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Saronno (VA)
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Sittard-geleen
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Levanger
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
state: Sector 2
city: Kuzmolovo, Vsevolozhsk district
country: Russian Federation
facility: Pfizer Investigational Site
state: Leningrad region
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Burgos
country: Spain
facility: Pfizer Investigational Site
city: Cadiz
country: Spain
facility: Pfizer Investigational Site
city: La Coruña
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Truro
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Chelmsford
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: Harlow
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: Burton upon Trent
country: United Kingdom
facility: Pfizer Investigational Site
state: Staffordshire
city: Worthing
country: United Kingdom
facility: Pfizer Investigational Site
state: West Sussex
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Essex
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Swansea
country: United Kingdom
facility: Pfizer Investigational Site
city: Truro
country: United Kingdom
facility: Pfizer Investigational Site
city: Worthing
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Crown JP, Dieras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.