A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
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
1 other identifier
interventional
488
4 countries
250
Brief Summary
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
Longer than P75 for phase_3
250 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
First Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedResults Posted
Study results publicly available
October 8, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedSeptember 10, 2012
September 1, 2012
2.6 years
September 7, 2006
June 1, 2010
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4
From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death
Secondary Outcomes (9)
Number of Participants With Objective Response
From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months
Duration of Response (DR)
From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause
Overall Survival (OS)
From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.
Percentage of Participants Surviving at 1 and 2 Years
Year 1, Year 2
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
- +4 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (250)
Pfizer Investigational Site
Bessemer, Alabama, 35022, United States
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
Pfizer Investigational Site
Birmingham, Alabama, 35211, United States
Pfizer Investigational Site
Birmingham, Alabama, 35213, United States
Pfizer Investigational Site
Birmingham, Alabama, 35235, United States
Pfizer Investigational Site
Daphne, Alabama, 36526, United States
Pfizer Investigational Site
Mobile, Alabama, 36604, United States
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Pfizer Investigational Site
Flagstaff, Arizona, 86001, United States
Pfizer Investigational Site
Sedona, Arizona, 86336, United States
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Pfizer Investigational Site
Anaheim, California, 92807, United States
Pfizer Investigational Site
Antioch, California, 94509, United States
Pfizer Investigational Site
Antioch, California, 94531, United States
Pfizer Investigational Site
Baldwin Park, California, 91706, United States
Pfizer Investigational Site
Bellflower, California, 90706, United States
Pfizer Investigational Site
Fontana, California, 92335, United States
Pfizer Investigational Site
Fountain Valley, California, 92708, United States
Pfizer Investigational Site
Gilroy, California, 95020, United States
Pfizer Investigational Site
Hawthorne, California, 90250, United States
Pfizer Investigational Site
Hayward, California, 94545, United States
Pfizer Investigational Site
Irvine, California, 92618, United States
Pfizer Investigational Site
La Jolla, California, 92093, United States
Pfizer Investigational Site
Long Beach, California, 90806, United States
Pfizer Investigational Site
Los Angeles, California, 90025, United States
Pfizer Investigational Site
Los Angeles, California, 90027, United States
Pfizer Investigational Site
Los Angeles, California, 90034, United States
Pfizer Investigational Site
Martinez, California, 94553, United States
Pfizer Investigational Site
Milpitas, California, 95035, United States
Pfizer Investigational Site
Modesto, California, 95356, United States
Pfizer Investigational Site
Mountain View, California, 94041, United States
Pfizer Investigational Site
Oakland, California, 94611, United States
Pfizer Investigational Site
Ontario, California, 91761, United States
Pfizer Investigational Site
Orange, California, 92868, United States
Pfizer Investigational Site
Oxnard, California, 93030, United States
Pfizer Investigational Site
Panorama City, California, 91402, United States
Pfizer Investigational Site
Pinole, California, 94564, United States
Pfizer Investigational Site
Riverside, California, 92505, United States
Pfizer Investigational Site
Sacramento, California, 95817, United States
Pfizer Investigational Site
San Diego, California, 92108, United States
Pfizer Investigational Site
San Diego, California, 92120, United States
Pfizer Investigational Site
San Francisco, California, 94080, United States
Pfizer Investigational Site
San Francisco, California, 94115, United States
Pfizer Investigational Site
San Francisco, California, 94118, United States
Pfizer Investigational Site
San Jose, California, 95119, United States
Pfizer Investigational Site
San Sacramento, California, 95825, United States
Pfizer Investigational Site
Santa Clara, California, 95051, United States
Pfizer Investigational Site
Santa Monica, California, 90404, United States
Pfizer Investigational Site
Union City, California, 94587, United States
Pfizer Investigational Site
Vallejo, California, 94589, United States
Pfizer Investigational Site
Walnut Creek, California, 94596, United States
Pfizer Investigational Site
Woodland Hills, California, 91365, United States
Pfizer Investigational Site
Aurora, Colorado, 80012, United States
Pfizer Investigational Site
Boulder, Colorado, 80303, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80907, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80909, United States
Pfizer Investigational Site
Denver, Colorado, 80218, United States
Pfizer Investigational Site
Denver, Colorado, 80220, United States
Pfizer Investigational Site
Lakewood, Colorado, 80228, United States
Pfizer Investigational Site
Littleton, Colorado, 80120, United States
Pfizer Investigational Site
Lone Tree, Colorado, 80214, United States
Pfizer Investigational Site
Longmont, Colorado, 80501, United States
Pfizer Investigational Site
Parker, Colorado, 80138, United States
Pfizer Investigational Site
Thornton, Colorado, 80260, United States
Pfizer Investigational Site
Norwalk, Connecticut, 06856, United States
Pfizer Investigational Site
Boca Raton, Florida, 33428, United States
Pfizer Investigational Site
Coral Springs, Florida, 33065, United States
Pfizer Investigational Site
Davie, Florida, 33328, United States
Pfizer Investigational Site
Hollywood, Florida, 33021, United States
Pfizer Investigational Site
Inverness, Florida, 34452, United States
Pfizer Investigational Site
Lakeland, Florida, 33805, United States
Pfizer Investigational Site
Melbourne, Florida, 32901, United States
Pfizer Investigational Site
Miami, Florida, 33125, United States
Pfizer Investigational Site
Miami, Florida, 33129, United States
Pfizer Investigational Site
Miami, Florida, 33133, United States
Pfizer Investigational Site
Orlando, Florida, 32806, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33028, United States
Pfizer Investigational Site
Tampa, Florida, 33612-9497, United States
Pfizer Investigational Site
Winter Park, Florida, 32789, United States
Pfizer Investigational Site
Atlanta, Georgia, 30341, United States
Pfizer Investigational Site
Atlanta, Georgia, 30342, United States
Pfizer Investigational Site
Columbus, Georgia, 31902, United States
Pfizer Investigational Site
Columbus, Georgia, 31904, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Macon, Georgia, 31217, United States
Pfizer Investigational Site
Marietta, Georgia, 30060, United States
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
Pfizer Investigational Site
Harvey, Illinois, 60426, United States
Pfizer Investigational Site
Skokie, Illinois, 60076, United States
Pfizer Investigational Site
Tinley Park, Illinois, 60477, United States
Pfizer Investigational Site
Vernon Hills, Illinois, 60061, United States
Pfizer Investigational Site
Avon, Indiana, 46123, United States
Pfizer Investigational Site
Beech Grove, Indiana, 46107, United States
Pfizer Investigational Site
Carmel, Indiana, 46032, United States
Pfizer Investigational Site
Fishers, Indiana, 46037, United States
Pfizer Investigational Site
Greenfield, Indiana, 46140, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46219, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46227, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46237, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46254, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46260, United States
Pfizer Investigational Site
Jeffersonville, Indiana, 47130, United States
Pfizer Investigational Site
Mooresville, Indiana, 46158, United States
Pfizer Investigational Site
Munster, Indiana, 46321, United States
Pfizer Investigational Site
New Albany, Indiana, 47150-6809, United States
Pfizer Investigational Site
Kansas City, Kansas, 66112, United States
Pfizer Investigational Site
Overland Park, Kansas, 66210, United States
Pfizer Investigational Site
Louisville, Kentucky, 40202, United States
Pfizer Investigational Site
Louisville, Kentucky, 40207, United States
Pfizer Investigational Site
Louisville, Kentucky, 40217, United States
Pfizer Investigational Site
Louisville, Kentucky, 40241, United States
Pfizer Investigational Site
Louisville, Kentucky, 40245, United States
Pfizer Investigational Site
Annapolis, Maryland, 21401, United States
Pfizer Investigational Site
Baltimore, Maryland, 21202, United States
Pfizer Investigational Site
Baltimore, Maryland, 21215, United States
Pfizer Investigational Site
Baltimore, Maryland, 21225, United States
Pfizer Investigational Site
Baltimore, Maryland, 21229, United States
Pfizer Investigational Site
Columbia, Maryland, 21044, United States
Pfizer Investigational Site
Randallstown, Maryland, 21133, United States
Pfizer Investigational Site
Burlington, Massachusetts, 01805, United States
Pfizer Investigational Site
Peabody, Massachusetts, 01960, United States
Pfizer Investigational Site
Coon Rapids, Minnesota, 55433, United States
Pfizer Investigational Site
Robbinsdale, Minnesota, 55422, United States
Pfizer Investigational Site
Ocean Springs, Mississippi, 39564, United States
Pfizer Investigational Site
Pascagoula, Mississippi, 39581, United States
Pfizer Investigational Site
Columbia, Missouri, 65201, United States
Pfizer Investigational Site
Kansas City, Missouri, 64111, United States
Pfizer Investigational Site
Kansas City, Missouri, 64131, United States
Pfizer Investigational Site
Kansas City, Missouri, 64154, United States
Pfizer Investigational Site
Lee's Summit, Missouri, 64064, United States
Pfizer Investigational Site
Fremont, Nebraska, 68025, United States
Pfizer Investigational Site
Grand Island, Nebraska, 68803, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68502, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68506, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68510, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68516, United States
Pfizer Investigational Site
Henderson, Nevada, 89052, United States
Pfizer Investigational Site
Henderson, Nevada, 89074, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89102, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89106, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89109, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89128, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89148, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89169, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87106, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87109, United States
Pfizer Investigational Site
Buffalo, New York, 14263, United States
Pfizer Investigational Site
Corning, New York, 14830, United States
Pfizer Investigational Site
Jamaica, New York, 11432, United States
Pfizer Investigational Site
Mineola, New York, 11501, United States
Pfizer Investigational Site
Cary, North Carolina, 27518, United States
Pfizer Investigational Site
Clinton, North Carolina, 28328, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Goldsboro, North Carolina, 27534, United States
Pfizer Investigational Site
Hickory, North Carolina, 28602, United States
Pfizer Investigational Site
Kenansville, North Carolina, 28349, United States
Pfizer Investigational Site
Kinston, North Carolina, 28501, United States
Pfizer Investigational Site
Lenoir, North Carolina, 28645, United States
Pfizer Investigational Site
Pollocksville, North Carolina, 28573, United States
Pfizer Investigational Site
Raleight, North Carolina, 27614, United States
Pfizer Investigational Site
Raliegh, North Carolina, 27607, United States
Pfizer Investigational Site
Richlands, North Carolina, 28574, United States
Pfizer Investigational Site
Washington, North Carolina, 27889, United States
Pfizer Investigational Site
Wilson, North Carolina, 27893, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157, United States
Pfizer Investigational Site
Canton, Ohio, 44718, United States
Pfizer Investigational Site
Dover, Ohio, 44622, United States
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Portland, Oregon, 97213, United States
Pfizer Investigational Site
Portland, Oregon, 97225, United States
Pfizer Investigational Site
Portland, Oregon, 97227, United States
Pfizer Investigational Site
Portland, Oregon, 97239, United States
Pfizer Investigational Site
Springfield, Oregon, 97477, United States
Pfizer Investigational Site
Tualatin, Oregon, 97062, United States
Pfizer Investigational Site
Allentown, Pennsylvania, 18104, United States
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015, United States
Pfizer Investigational Site
Ephrata, Pennsylvania, 17522, United States
Pfizer Investigational Site
Hershey, Pennsylvania, 17033, United States
Pfizer Investigational Site
Kingston, Pennsylvania, 18704, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15232, United States
Pfizer Investigational Site
Sayre, Pennsylvania, 18840, United States
Pfizer Investigational Site
Charleston, South Carolina, 29406-9173, United States
Pfizer Investigational Site
Easley, South Carolina, 29640, United States
Pfizer Investigational Site
Greenville, South Carolina, 29605, United States
Pfizer Investigational Site
Greenville, South Carolina, 29615, United States
Pfizer Investigational Site
Seneca, South Carolina, 29672, United States
Pfizer Investigational Site
Spartanburg, South Carolina, 29307, United States
Pfizer Investigational Site
Bristol, Tennessee, 37620, United States
Pfizer Investigational Site
Kingsport, Tennessee, 37660, United States
Pfizer Investigational Site
Amarillo, Texas, 79106, United States
Pfizer Investigational Site
Antonio, Texas, 78212, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Austin, Texas, 78731, United States
Pfizer Investigational Site
Austin, Texas, 78758, United States
Pfizer Investigational Site
Austin, Texas, 78759-5249, United States
Pfizer Investigational Site
Bedford, Texas, 76022, United States
Pfizer Investigational Site
Corpus Christi, Texas, 78405, United States
Pfizer Investigational Site
Dallas, Texas, 75231, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Fort Worth, Texas, 76104, United States
Pfizer Investigational Site
Fort Worth, Texas, 76132, United States
Pfizer Investigational Site
Fort Worth, Texas, 76177, United States
Pfizer Investigational Site
Forth Worth, Texas, 76177, United States
Pfizer Investigational Site
Houston, Texas, 77024, United States
Pfizer Investigational Site
Houston, Texas, 77090, United States
Pfizer Investigational Site
Houston, Texas, 77429, United States
Pfizer Investigational Site
Kerrville, Texas, 78217, United States
Pfizer Investigational Site
Longview, Texas, 75601, United States
Pfizer Investigational Site
Midland, Texas, 79701-5946, United States
Pfizer Investigational Site
Round Rock, Texas, 78665, United States
Pfizer Investigational Site
Round Rock, Texas, 78681, United States
Pfizer Investigational Site
Round Rock, Texas, 78745, United States
Pfizer Investigational Site
San Antonio, Texas, 78217, United States
Pfizer Investigational Site
San Antonio, Texas, 78258, United States
Pfizer Investigational Site
San Marcos, Texas, 78666, United States
Pfizer Investigational Site
Shenandoah, Texas, 77384, United States
Pfizer Investigational Site
Tyler, Texas, 75702, United States
Pfizer Investigational Site
Waco, Texas, 76712, United States
Pfizer Investigational Site
Ogden, Utah, 84403-3274, United States
Pfizer Investigational Site
Arlington, Virginia, 22205, United States
Pfizer Investigational Site
Christiansburg, Virginia, 24073, United States
Pfizer Investigational Site
Fairfax, Virginia, 22031, United States
Pfizer Investigational Site
Leesburg, Virginia, 20176, United States
Pfizer Investigational Site
Norton, Virginia, 24273, United States
Pfizer Investigational Site
Roanoke, Virginia, 24014, United States
Pfizer Investigational Site
Salem, Virginia, 24153, United States
Pfizer Investigational Site
Woodbridge, Virginia, 22191, United States
Pfizer Investigational Site
Wytheville, Virginia, 24382, United States
Pfizer Investigational Site
Federal Way, Washington, 98003, United States
Pfizer Investigational Site
Kennewick, Washington, 99336, United States
Pfizer Investigational Site
Lakewood, Washington, 98499, United States
Pfizer Investigational Site
Moses Lake, Washington, 98837, United States
Pfizer Investigational Site
Puyallup, Washington, 98372, United States
Pfizer Investigational Site
Tacoma, Washington, 98405, United States
Pfizer Investigational Site
Vancouver, Washington, 98684, United States
Pfizer Investigational Site
Vancouver, Washington, 98686, United States
Pfizer Investigational Site
Wenatchee, Washington, 98801, United States
Pfizer Investigational Site
Huntington, West Virginia, 25701, United States
Pfizer Investigational Site
Morgantown, West Virginia, 26506, United States
Pfizer Investigational Site
Berlin, 14195, Germany
Pfizer Investigational Site
Hamburg, 20246, Germany
Pfizer Investigational Site
Trier, 54290, Germany
Pfizer Investigational Site
Cremona, 26100, Italy
Pfizer Investigational Site
Grosseto, 58100, Italy
Pfizer Investigational Site
Olbia, 07026, Italy
Pfizer Investigational Site
Cabueñes, Gijon, 33394, Spain
Pfizer Investigational Site
Guadalajara, Guadalajara, 19002, Spain
Pfizer Investigational Site
Madrid, Madrid, 28033, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 8, 2006
Study Start
November 1, 2006
Primary Completion
June 1, 2009
Study Completion
August 1, 2011
Last Updated
September 10, 2012
Results First Posted
October 8, 2010
Record last verified: 2012-09