Clinical trial NCT00373256: A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Official title: A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: Breast cancer
advanced
sunitinib
bevacizumab
paclitaxel
Phase 3
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-08
Enrollment: 488
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: To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

Detailed description: On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced breast cancer.
* Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

* No prior treatment with cytotoxics in the advanced disease setting.
* HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
* Treatment with a taxane in the adjuvant setting unless disease free interval \>12 months after end of treatment.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death
Secondary outcomes:
measure: Number of Participants With Objective Response
timeFrame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months
measure: Duration of Response (DR)
timeFrame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause
measure: Overall Survival (OS)
timeFrame: From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.
measure: Percentage of Participants Surviving at 1 and 2 Years
timeFrame: Year 1, Year 2
measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
measure: EORTC QLQ Breast Cancer Module (BR23)
timeFrame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
measure: Euro Quality of Life-5 Dimension (EQ-5D)
timeFrame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
measure: EQ - Visual Analog Scale (EQ-VAS)
timeFrame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
measure: Biomarkers
timeFrame: Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Daphne
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Flagstaff
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sedona
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Antioch
country: United States
facility: Pfizer Investigational Site
state: California
city: Antioch
country: United States
facility: Pfizer Investigational Site
state: California
city: Baldwin Park
country: United States
facility: Pfizer Investigational Site
state: California
city: Bellflower
country: United States
facility: Pfizer Investigational Site
state: California
city: Fontana
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Gilroy
country: United States
facility: Pfizer Investigational Site
state: California
city: Hawthorne
country: United States
facility: Pfizer Investigational Site
state: California
city: Hayward
country: United States
facility: Pfizer Investigational Site
state: California
city: Irvine
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Martinez
country: United States
facility: Pfizer Investigational Site
state: California
city: Milpitas
country: United States
facility: Pfizer Investigational Site
state: California
city: Modesto
country: United States
facility: Pfizer Investigational Site
state: California
city: Mountain View
country: United States
facility: Pfizer Investigational Site
state: California
city: Oakland
country: United States
facility: Pfizer Investigational Site
state: California
city: Ontario
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Oxnard
country: United States
facility: Pfizer Investigational Site
state: California
city: Panorama City
country: United States
facility: Pfizer Investigational Site
state: California
city: Pinole
country: United States
facility: Pfizer Investigational Site
state: California
city: Riverside
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Jose
country: United States
facility: Pfizer Investigational Site
state: California
city: San Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Clara
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Union City
country: United States
facility: Pfizer Investigational Site
state: California
city: Vallejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Woodland Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lone Tree
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Longmont
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Parker
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Thornton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Norwalk
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Coral Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Davie
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Inverness
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
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: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Harvey
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Tinley Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Vernon Hills
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Avon
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Beech Grove
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Carmel
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fishers
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Greenfield
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Mooresville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Munster
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Annapolis
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Randallstown
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Peabody
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Coon Rapids
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Robbinsdale
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Ocean Springs
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Pascagoula
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lee's Summit
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Fremont
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Grand Island
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
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: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Corning
country: United States
facility: Pfizer Investigational Site
state: New York
city: Jamaica
country: United States
facility: Pfizer Investigational Site
state: New York
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Clinton
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Goldsboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kenansville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kinston
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lenoir
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Pollocksville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleight
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raliegh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Richlands
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Washington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilson
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dover
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Tualatin
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Ephrata
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Kingston
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: Sayre
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Easley
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Seneca
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Antonio
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: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bedford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Forth Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Kerrville
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Midland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Marcos
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Shenandoah
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Waco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Ogden
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Christiansburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Fairfax
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Leesburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norton
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Salem
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Woodbridge
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Wytheville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kennewick
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Moses Lake
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Puyallup
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Huntington
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Morgantown
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Trier
country: Germany
facility: Pfizer Investigational Site
city: Cremona
country: Italy
facility: Pfizer Investigational Site
city: Grosseto
country: Italy
facility: Pfizer Investigational Site
city: Olbia
country: Italy
facility: Pfizer Investigational Site
city: Cabueñes
country: Spain
facility: Pfizer Investigational Site
state: Gijon
city: Guadalajara
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: