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Breast NeoplasmsPhase 3NCT00373256

A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

A Phase 3 study testing Sunitinib, paclitaxel and bevacizumab in people with Breast Neoplasms, run by Pfizer at 250 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Sunitinib, paclitaxel and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
250 sitesin 4 countries
Study dates
Nov 2006to Aug 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

250 sites in 4 countries.

250 sites in 4 countries

United States241 sites

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87106

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87109

  • Pfizer Investigational Site

    Allentown, Pennsylvania, 18104

  • Pfizer Investigational Site

    Amarillo, Texas, 79106

  • Pfizer Investigational Site

    Anaheim, California, 92807

  • Pfizer Investigational Site

    Annapolis, Maryland, 21401

  • Pfizer Investigational Site

    Antioch, California, 94509

  • Pfizer Investigational Site

    Antioch, California, 94531

  • Pfizer Investigational Site

    Antonio, Texas, 78212

  • Pfizer Investigational Site

    Arlington, Virginia, 22205

  • Pfizer Investigational Site

    Atlanta, Georgia, 30341

  • Pfizer Investigational Site

    Atlanta, Georgia, 30342

  • Pfizer Investigational Site

    Aurora, Colorado, 80012

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Austin, Texas, 78731

  • Pfizer Investigational Site

    Austin, Texas, 78758

  • Pfizer Investigational Site

    Austin, Texas, 78759-5249

  • Pfizer Investigational Site

    Avon, Indiana, 46123

  • Pfizer Investigational Site

    Baldwin Park, California, 91706

  • Pfizer Investigational Site

    Baltimore, Maryland, 21202

  • Pfizer Investigational Site

    Baltimore, Maryland, 21215

  • Pfizer Investigational Site

    Baltimore, Maryland, 21225

  • Pfizer Investigational Site

    Baltimore, Maryland, 21229

  • Pfizer Investigational Site

    Bedford, Texas, 76022

  • Pfizer Investigational Site

    Beech Grove, Indiana, 46107

  • Pfizer Investigational Site

    Bellflower, California, 90706

  • Pfizer Investigational Site

    Bessemer, Alabama, 35022

  • Pfizer Investigational Site

    Bethlehem, Pennsylvania, 18015

  • Pfizer Investigational Site

    Birmingham, Alabama, 35205

  • Pfizer Investigational Site

    Birmingham, Alabama, 35209

  • Pfizer Investigational Site

    Birmingham, Alabama, 35211

  • Pfizer Investigational Site

    Birmingham, Alabama, 35213

  • Pfizer Investigational Site

    Birmingham, Alabama, 35235

  • Pfizer Investigational Site

    Boca Raton, Florida, 33428

  • Pfizer Investigational Site

    Boulder, Colorado, 80303

  • Pfizer Investigational Site

    Bristol, Tennessee, 37620

  • Pfizer Investigational Site

    Buffalo, New York, 14263

  • Pfizer Investigational Site

    Burlington, Massachusetts, 01805

  • Pfizer Investigational Site

    Canton, Ohio, 44718

  • Pfizer Investigational Site

    Carmel, Indiana, 46032

  • Pfizer Investigational Site

    Cary, North Carolina, 27518

  • Pfizer Investigational Site

    Charleston, South Carolina, 29406-9173

  • Pfizer Investigational Site

    Chicago, Illinois, 60612

  • Pfizer Investigational Site

    Christiansburg, Virginia, 24073

  • Pfizer Investigational Site

    Clinton, North Carolina, 28328

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80907

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80909

  • Pfizer Investigational Site

    Columbia, Maryland, 21044

  • Pfizer Investigational Site

    Columbia, Missouri, 65201

  • Pfizer Investigational Site

    Columbus, Georgia, 31902

  • Pfizer Investigational Site

    Columbus, Georgia, 31904

  • Pfizer Investigational Site

    Coon Rapids, Minnesota, 55433

  • Pfizer Investigational Site

    Coral Springs, Florida, 33065

  • Pfizer Investigational Site

    Corning, New York, 14830

  • Pfizer Investigational Site

    Corpus Christi, Texas, 78405

  • Pfizer Investigational Site

    Dallas, Texas, 75231

  • Pfizer Investigational Site

    Dallas, Texas, 75246

  • Pfizer Investigational Site

    Daphne, Alabama, 36526

  • Pfizer Investigational Site

    Davie, Florida, 33328

  • Pfizer Investigational Site

    Decatur, Georgia, 30033

  • Pfizer Investigational Site

    Denver, Colorado, 80218

  • Pfizer Investigational Site

    Denver, Colorado, 80220

  • Pfizer Investigational Site

    Dover, Ohio, 44622

  • Pfizer Investigational Site

    Durham, North Carolina, 27710

  • Pfizer Investigational Site

    Easley, South Carolina, 29640

  • Pfizer Investigational Site

    Ephrata, Pennsylvania, 17522

  • Pfizer Investigational Site

    Eugene, Oregon, 97401

  • Pfizer Investigational Site

    Fairfax, Virginia, 22031

  • Pfizer Investigational Site

    Federal Way, Washington, 98003

  • Pfizer Investigational Site

    Fishers, Indiana, 46037

  • Pfizer Investigational Site

    Flagstaff, Arizona, 86001

  • Pfizer Investigational Site

    Fontana, California, 92335

  • Pfizer Investigational Site

    Fort Worth, Texas, 76104

  • Pfizer Investigational Site

    Fort Worth, Texas, 76132

  • Pfizer Investigational Site

    Fort Worth, Texas, 76177

  • Pfizer Investigational Site

    Forth Worth, Texas, 76177

  • Pfizer Investigational Site

    Fountain Valley, California, 92708

  • Pfizer Investigational Site

    Fremont, Nebraska, 68025

  • Pfizer Investigational Site

    Gilroy, California, 95020

  • Pfizer Investigational Site

    Goldsboro, North Carolina, 27534

  • Pfizer Investigational Site

    Grand Island, Nebraska, 68803

  • Pfizer Investigational Site

    Greenfield, Indiana, 46140

  • Pfizer Investigational Site

    Greenville, South Carolina, 29605

  • Pfizer Investigational Site

    Greenville, South Carolina, 29615

  • Pfizer Investigational Site

    Harvey, Illinois, 60426

  • Pfizer Investigational Site

    Hawthorne, California, 90250

  • Pfizer Investigational Site

    Hayward, California, 94545

  • Pfizer Investigational Site

    Henderson, Nevada, 89052

  • Pfizer Investigational Site

    Henderson, Nevada, 89074

  • Pfizer Investigational Site

    Hershey, Pennsylvania, 17033

  • Pfizer Investigational Site

    Hickory, North Carolina, 28602

  • Pfizer Investigational Site

    Hollywood, Florida, 33021

  • Pfizer Investigational Site

    Hot Springs, Arkansas, 71913

  • Pfizer Investigational Site

    Houston, Texas, 77024

  • Pfizer Investigational Site

    Houston, Texas, 77090

  • Pfizer Investigational Site

    Houston, Texas, 77429

  • Pfizer Investigational Site

    Huntington, West Virginia, 25701

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46219

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46227

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46237

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46254

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46260

  • Pfizer Investigational Site

    Inverness, Florida, 34452

  • Pfizer Investigational Site

    Irvine, California, 92618

  • Pfizer Investigational Site

    Jamaica, New York, 11432

  • Pfizer Investigational Site

    Jeffersonville, Indiana, 47130

  • Pfizer Investigational Site

    Kansas City, Kansas, 66112

  • Pfizer Investigational Site

    Kansas City, Missouri, 64111

  • Pfizer Investigational Site

    Kansas City, Missouri, 64131

  • Pfizer Investigational Site

    Kansas City, Missouri, 64154

  • Pfizer Investigational Site

    Kenansville, North Carolina, 28349

  • Pfizer Investigational Site

    Kennewick, Washington, 99336

  • Pfizer Investigational Site

    Kerrville, Texas, 78217

  • Pfizer Investigational Site

    Kingsport, Tennessee, 37660

  • Pfizer Investigational Site

    Kingston, Pennsylvania, 18704

  • Pfizer Investigational Site

    Kinston, North Carolina, 28501

  • Pfizer Investigational Site

    La Jolla, California, 92093

  • Pfizer Investigational Site

    Lakeland, Florida, 33805

  • Pfizer Investigational Site

    Lakewood, Colorado, 80228

  • Pfizer Investigational Site

    Lakewood, Washington, 98499

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89102

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89106

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89109

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89128

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89148

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89169

  • Pfizer Investigational Site

    Lee's Summit, Missouri, 64064

  • Pfizer Investigational Site

    Leesburg, Virginia, 20176

  • Pfizer Investigational Site

    Lenoir, North Carolina, 28645

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68502

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68506

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68510

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68516

  • Pfizer Investigational Site

    Littleton, Colorado, 80120

  • Pfizer Investigational Site

    Lone Tree, Colorado, 80214

  • Pfizer Investigational Site

    Long Beach, California, 90806

  • Pfizer Investigational Site

    Longmont, Colorado, 80501

  • Pfizer Investigational Site

    Longview, Texas, 75601

  • Pfizer Investigational Site

    Los Angeles, California, 90025

  • Pfizer Investigational Site

    Los Angeles, California, 90027

  • Pfizer Investigational Site

    Los Angeles, California, 90034

  • Pfizer Investigational Site

    Louisville, Kentucky, 40202

  • Pfizer Investigational Site

    Louisville, Kentucky, 40207

  • Pfizer Investigational Site

    Louisville, Kentucky, 40217

  • Pfizer Investigational Site

    Louisville, Kentucky, 40241

  • Pfizer Investigational Site

    Louisville, Kentucky, 40245

  • Pfizer Investigational Site

    Macon, Georgia, 31217

  • Pfizer Investigational Site

    Marietta, Georgia, 30060

  • Pfizer Investigational Site

    Martinez, California, 94553

  • Pfizer Investigational Site

    Melbourne, Florida, 32901

  • Pfizer Investigational Site

    Miami, Florida, 33125

  • Pfizer Investigational Site

    Miami, Florida, 33129

  • Pfizer Investigational Site

    Miami, Florida, 33133

  • Pfizer Investigational Site

    Midland, Texas, 79701-5946

  • Pfizer Investigational Site

    Milpitas, California, 95035

  • Pfizer Investigational Site

    Mineola, New York, 11501

  • Pfizer Investigational Site

    Mobile, Alabama, 36604

  • Pfizer Investigational Site

    Mobile, Alabama, 36608

  • Pfizer Investigational Site

    Modesto, California, 95356

  • Pfizer Investigational Site

    Mooresville, Indiana, 46158

  • Pfizer Investigational Site

    Morgantown, West Virginia, 26506

  • Pfizer Investigational Site

    Moses Lake, Washington, 98837

  • Pfizer Investigational Site

    Mountain View, California, 94041

  • Pfizer Investigational Site

    Munster, Indiana, 46321

  • Pfizer Investigational Site

    New Albany, Indiana, 47150-6809

  • Pfizer Investigational Site

    Norton, Virginia, 24273

  • Pfizer Investigational Site

    Norwalk, Connecticut, 06856

  • Pfizer Investigational Site

    Oakland, California, 94611

  • Pfizer Investigational Site

    Ocean Springs, Mississippi, 39564

  • Pfizer Investigational Site

    Ogden, Utah, 84403-3274

  • Pfizer Investigational Site

    Ontario, California, 91761

  • Pfizer Investigational Site

    Orange, California, 92868

  • Pfizer Investigational Site

    Orlando, Florida, 32806

  • Pfizer Investigational Site

    Overland Park, Kansas, 66210

  • Pfizer Investigational Site

    Oxnard, California, 93030

  • Pfizer Investigational Site

    Panorama City, California, 91402

  • Pfizer Investigational Site

    Parker, Colorado, 80138

  • Pfizer Investigational Site

    Pascagoula, Mississippi, 39581

  • Pfizer Investigational Site

    Peabody, Massachusetts, 01960

  • Pfizer Investigational Site

    Pembroke Pines, Florida, 33028

  • Pfizer Investigational Site

    Pinole, California, 94564

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • Pfizer Investigational Site

    Pollocksville, North Carolina, 28573

  • Pfizer Investigational Site

    Portland, Oregon, 97213

  • Pfizer Investigational Site

    Portland, Oregon, 97225

  • Pfizer Investigational Site

    Portland, Oregon, 97227

  • Pfizer Investigational Site

    Portland, Oregon, 97239

  • Pfizer Investigational Site

    Puyallup, Washington, 98372

  • Pfizer Investigational Site

    Raleight, North Carolina, 27614

  • Pfizer Investigational Site

    Raliegh, North Carolina, 27607

  • Pfizer Investigational Site

    Randallstown, Maryland, 21133

  • Pfizer Investigational Site

    Richlands, North Carolina, 28574

  • Pfizer Investigational Site

    Riverside, California, 92505

  • Pfizer Investigational Site

    Roanoke, Virginia, 24014

  • Pfizer Investigational Site

    Robbinsdale, Minnesota, 55422

  • Pfizer Investigational Site

    Round Rock, Texas, 78665

  • Pfizer Investigational Site

    Round Rock, Texas, 78681

  • Pfizer Investigational Site

    Round Rock, Texas, 78745

  • Pfizer Investigational Site

    Sacramento, California, 95817

  • Pfizer Investigational Site

    Salem, Virginia, 24153

  • Pfizer Investigational Site

    San Antonio, Texas, 78217

  • Pfizer Investigational Site

    San Antonio, Texas, 78258

  • Pfizer Investigational Site

    San Diego, California, 92108

  • Pfizer Investigational Site

    San Diego, California, 92120

  • Pfizer Investigational Site

    San Francisco, California, 94080

  • Pfizer Investigational Site

    San Francisco, California, 94115

  • Pfizer Investigational Site

    San Francisco, California, 94118

  • Pfizer Investigational Site

    San Jose, California, 95119

  • Pfizer Investigational Site

    San Marcos, Texas, 78666

  • Pfizer Investigational Site

    San Sacramento, California, 95825

  • Pfizer Investigational Site

    Santa Clara, California, 95051

  • Pfizer Investigational Site

    Santa Monica, California, 90404

  • Pfizer Investigational Site

    Sayre, Pennsylvania, 18840

  • Pfizer Investigational Site

    Sedona, Arizona, 86336

  • Pfizer Investigational Site

    Seneca, South Carolina, 29672

  • Pfizer Investigational Site

    Shenandoah, Texas, 77384

  • Pfizer Investigational Site

    Skokie, Illinois, 60076

  • Pfizer Investigational Site

    Spartanburg, South Carolina, 29307

  • Pfizer Investigational Site

    Springfield, Oregon, 97477

  • Pfizer Investigational Site

    Tacoma, Washington, 98405

  • Pfizer Investigational Site

    Tampa, Florida, 33612-9497

  • Pfizer Investigational Site

    Thornton, Colorado, 80260

  • Pfizer Investigational Site

    Tinley Park, Illinois, 60477

  • Pfizer Investigational Site

    Tualatin, Oregon, 97062

  • Pfizer Investigational Site

    Tyler, Texas, 75702

  • Pfizer Investigational Site

    Union City, California, 94587

  • Pfizer Investigational Site

    Vallejo, California, 94589

  • Pfizer Investigational Site

    Vancouver, Washington, 98684

  • Pfizer Investigational Site

    Vancouver, Washington, 98686

  • Pfizer Investigational Site

    Vernon Hills, Illinois, 60061

  • Pfizer Investigational Site

    Waco, Texas, 76712

  • Pfizer Investigational Site

    Walnut Creek, California, 94596

  • Pfizer Investigational Site

    Washington, North Carolina, 27889

  • Pfizer Investigational Site

    Wenatchee, Washington, 98801

  • Pfizer Investigational Site

    Wilson, North Carolina, 27893

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27157

  • Pfizer Investigational Site

    Winter Park, Florida, 32789

  • Pfizer Investigational Site

    Woodbridge, Virginia, 22191

  • Pfizer Investigational Site

    Woodland Hills, California, 91365

  • Pfizer Investigational Site

    Wytheville, Virginia, 24382

Other trials in United States

Germany3 sites

  • Pfizer Investigational Site

    Berlin, 14195

  • Pfizer Investigational Site

    Hamburg, 20246

  • Pfizer Investigational Site

    Trier, 54290

Other trials in Germany

Italy3 sites

  • Pfizer Investigational Site

    Cremona, 26100

  • Pfizer Investigational Site

    Grosseto, 58100

  • Pfizer Investigational Site

    Olbia, 07026

Other trials in Italy

Spain3 sites

  • Pfizer Investigational Site

    Cabueñes, Gijon, 33394

  • Pfizer Investigational Site

    Guadalajara, Guadalajara, 19002

  • Pfizer Investigational Site

    Madrid, Madrid, 28033

Other trials in Spain

About this study

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

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

Read the 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.

Keywords
Breast cancer, advanced, sunitinib, bevacizumab, paclitaxel, Phase 3
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunitinibDrug

    Also called SU011248, Sutent

    Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,

  • paclitaxelDrug

    Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

  • bevacizumabDrug

    Also called Avastin

    Bevacizumab 10 mg/kg IV every 2 weeks.

  • paclitaxelDrug

    Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

Study groups in NCT00373256
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Sunitinib; Drug: paclitaxel
BActive comparatorNot described
Receives: Drug: bevacizumab; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death

Secondary outcomes (9)

  1. Number of Participants With Objective Response

    Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

    Measured: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months

  2. Duration of Response (DR)

    DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as [the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)] divided by 30.4.

    Measured: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause

  3. Overall Survival (OS)

    OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.

    Measured: From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.

  4. Percentage of Participants Surviving at 1 and 2 Years

    Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.

    Measured: Year 1, Year 2

  5. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.

    Measured: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

  6. EORTC QLQ Breast Cancer Module (BR23)

    BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

    Measured: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

  7. Euro Quality of Life-5 Dimension (EQ-5D)

    EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.

    Measured: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

  8. EQ - Visual Analog Scale (EQ-VAS)

    EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.

    Measured: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

  9. Biomarkers

    Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 [VEGFR2] and VEGFR3, VEGF-A, placental growth factor [PlGF], soluble KIT, and possibly soluble PDGFRβ and PDGF) that may be associated with angiogenesis and tumor proliferation.

    Measured: Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJun 2009
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00373256
Sponsor's protocol ID
A6181094
Status last verified
Sep 2012
First submitted
7 Sep 2006
Last updated
10 Sep 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sunitinib, paclitaxel and bevacizumab in people with Breast Neoplasms, run by Pfizer at 250 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 250 sites in United States, Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00373256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.

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