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

September 5, 2012 updated by: Pfizer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

488

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14195
        • Pfizer Investigational Site
      • Hamburg, Germany, 20246
        • Pfizer Investigational Site
      • Trier, Germany, 54290
        • Pfizer Investigational Site
  • Italy
      • Cremona, Italy, 26100
        • Pfizer Investigational Site
      • Grosseto, Italy, 58100
        • Pfizer Investigational Site
      • Olbia, Italy, 07026
        • Pfizer Investigational Site
  • Spain
      • Guadalajara, Spain, 19002
        • Pfizer Investigational Site
      • Madrid, Spain, 28033
        • Pfizer Investigational Site
    • Gijon
      • Cabueñes, Gijon, Spain, 33394
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Bessemer, Alabama, United States, 35022
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35209
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35213
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35211
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35235
        • Pfizer Investigational Site
      • Daphne, Alabama, United States, 36526
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36604
        • Pfizer Investigational Site
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Pfizer Investigational Site
      • Sedona, Arizona, United States, 86336
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92807
        • Pfizer Investigational Site
      • Antioch, California, United States, 94531
        • Pfizer Investigational Site
      • Antioch, California, United States, 94509
        • Pfizer Investigational Site
      • Baldwin Park, California, United States, 91706
        • Pfizer Investigational Site
      • Bellflower, California, United States, 90706
        • Pfizer Investigational Site
      • Fontana, California, United States, 92335
        • Pfizer Investigational Site
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Gilroy, California, United States, 95020
        • Pfizer Investigational Site
      • Hawthorne, California, United States, 90250
        • Pfizer Investigational Site
      • Hayward, California, United States, 94545
        • Pfizer Investigational Site
      • Irvine, California, United States, 92618
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92093
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90027
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90025
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90034
        • Pfizer Investigational Site
      • Martinez, California, United States, 94553
        • Pfizer Investigational Site
      • Milpitas, California, United States, 95035
        • Pfizer Investigational Site
      • Modesto, California, United States, 95356
        • Pfizer Investigational Site
      • Mountain View, California, United States, 94041
        • Pfizer Investigational Site
      • Oakland, California, United States, 94611
        • Pfizer Investigational Site
      • Ontario, California, United States, 91761
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • Oxnard, California, United States, 93030
        • Pfizer Investigational Site
      • Panorama City, California, United States, 91402
        • Pfizer Investigational Site
      • Pinole, California, United States, 94564
        • Pfizer Investigational Site
      • Riverside, California, United States, 92505
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95817
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94118
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94080
        • Pfizer Investigational Site
      • San Jose, California, United States, 95119
        • Pfizer Investigational Site
      • San Sacramento, California, United States, 95825
        • Pfizer Investigational Site
      • Santa Clara, California, United States, 95051
        • Pfizer Investigational Site
      • Santa Monica, California, United States, 90404
        • Pfizer Investigational Site
      • Union City, California, United States, 94587
        • Pfizer Investigational Site
      • Vallejo, California, United States, 94589
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94596
        • Pfizer Investigational Site
      • Woodland Hills, California, United States, 91365
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
      • Boulder, Colorado, United States, 80303
        • Pfizer Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • Pfizer Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
      • Lakewood, Colorado, United States, 80228
        • Pfizer Investigational Site
      • Littleton, Colorado, United States, 80120
        • Pfizer Investigational Site
      • Lone Tree, Colorado, United States, 80214
        • Pfizer Investigational Site
      • Longmont, Colorado, United States, 80501
        • Pfizer Investigational Site
      • Parker, Colorado, United States, 80138
        • Pfizer Investigational Site
      • Thornton, Colorado, United States, 80260
        • Pfizer Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Pfizer Investigational Site
      • Coral Springs, Florida, United States, 33065
        • Pfizer Investigational Site
      • Davie, Florida, United States, 33328
        • Pfizer Investigational Site
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Inverness, Florida, United States, 34452
        • Pfizer Investigational Site
      • Lakeland, Florida, United States, 33805
        • Pfizer Investigational Site
      • Melbourne, Florida, United States, 32901
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33125
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33129
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33133
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33612-9497
        • Pfizer Investigational Site
      • Winter Park, Florida, United States, 32789
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Columbus, Georgia, United States, 31902
        • Pfizer Investigational Site
      • Columbus, Georgia, United States, 31904
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Macon, Georgia, United States, 31217
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Harvey, Illinois, United States, 60426
        • Pfizer Investigational Site
      • Skokie, Illinois, United States, 60076
        • Pfizer Investigational Site
      • Tinley Park, Illinois, United States, 60477
        • Pfizer Investigational Site
      • Vernon Hills, Illinois, United States, 60061
        • Pfizer Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Pfizer Investigational Site
      • Beech Grove, Indiana, United States, 46107
        • Pfizer Investigational Site
      • Carmel, Indiana, United States, 46032
        • Pfizer Investigational Site
      • Fishers, Indiana, United States, 46037
        • Pfizer Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46227
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46237
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46254
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46219
        • Pfizer Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • Pfizer Investigational Site
      • Mooresville, Indiana, United States, 46158
        • Pfizer Investigational Site
      • Munster, Indiana, United States, 46321
        • Pfizer Investigational Site
      • New Albany, Indiana, United States, 47150-6809
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40241
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40245
        • Pfizer Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21229
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21202
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21215
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21225
        • Pfizer Investigational Site
      • Columbia, Maryland, United States, 21044
        • Pfizer Investigational Site
      • Randallstown, Maryland, United States, 21133
        • Pfizer Investigational Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Pfizer Investigational Site
      • Peabody, Massachusetts, United States, 01960
        • Pfizer Investigational Site
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Pfizer Investigational Site
      • Robbinsdale, Minnesota, United States, 55422
        • Pfizer Investigational Site
    • Mississippi
      • Ocean Springs, Mississippi, United States, 39564
        • Pfizer Investigational Site
      • Pascagoula, Mississippi, United States, 39581
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64111
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64131
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64154
        • Pfizer Investigational Site
      • Lee's Summit, Missouri, United States, 64064
        • Pfizer Investigational Site
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Pfizer Investigational Site
      • Grand Island, Nebraska, United States, 68803
        • Pfizer Investigational Site
      • Lincoln, Nebraska, United States, 68506
        • Pfizer Investigational Site
      • Lincoln, Nebraska, United States, 68510
        • Pfizer Investigational Site
      • Lincoln, Nebraska, United States, 68516
        • Pfizer Investigational Site
      • Lincoln, Nebraska, United States, 68502
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, United States, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89102
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89148
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89109
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89169
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14263
        • Pfizer Investigational Site
      • Corning, New York, United States, 14830
        • Pfizer Investigational Site
      • Jamaica, New York, United States, 11432
        • Pfizer Investigational Site
      • Mineola, New York, United States, 11501
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Pfizer Investigational Site
      • Clinton, North Carolina, United States, 28328
        • Pfizer Investigational Site
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, United States, 27534
        • Pfizer Investigational Site
      • Hickory, North Carolina, United States, 28602
        • Pfizer Investigational Site
      • Kenansville, North Carolina, United States, 28349
        • Pfizer Investigational Site
      • Kinston, North Carolina, United States, 28501
        • Pfizer Investigational Site
      • Lenoir, North Carolina, United States, 28645
        • Pfizer Investigational Site
      • Pollocksville, North Carolina, United States, 28573
        • Pfizer Investigational Site
      • Raleight, North Carolina, United States, 27614
        • Pfizer Investigational Site
      • Raliegh, North Carolina, United States, 27607
        • Pfizer Investigational Site
      • Richlands, North Carolina, United States, 28574
        • Pfizer Investigational Site
      • Washington, North Carolina, United States, 27889
        • Pfizer Investigational Site
      • Wilson, North Carolina, United States, 27893
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27157
        • Pfizer Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Pfizer Investigational Site
      • Dover, Ohio, United States, 44622
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97213
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97225
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97227
        • Pfizer Investigational Site
      • Springfield, Oregon, United States, 97477
        • Pfizer Investigational Site
      • Tualatin, Oregon, United States, 97062
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Pfizer Investigational Site
      • Bethlehem, Pennsylvania, United States, 18015
        • Pfizer Investigational Site
      • Ephrata, Pennsylvania, United States, 17522
        • Pfizer Investigational Site
      • Hershey, Pennsylvania, United States, 17033
        • Pfizer Investigational Site
      • Kingston, Pennsylvania, United States, 18704
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Pfizer Investigational Site
      • Sayre, Pennsylvania, United States, 18840
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406-9173
        • Pfizer Investigational Site
      • Easley, South Carolina, United States, 29640
        • Pfizer Investigational Site
      • Greenville, South Carolina, United States, 29615
        • Pfizer Investigational Site
      • Greenville, South Carolina, United States, 29605
        • Pfizer Investigational Site
      • Seneca, South Carolina, United States, 29672
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29307
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Pfizer Investigational Site
      • Antonio, Texas, United States, 78212
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78731
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78758
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78759-5249
        • Pfizer Investigational Site
      • Bedford, Texas, United States, 76022
        • Pfizer Investigational Site
      • Corpus Christi, Texas, United States, 78405
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76177
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76132
        • Pfizer Investigational Site
      • Forth Worth, Texas, United States, 76177
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77090
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77429
        • Pfizer Investigational Site
      • Kerrville, Texas, United States, 78217
        • Pfizer Investigational Site
      • Longview, Texas, United States, 75601
        • Pfizer Investigational Site
      • Midland, Texas, United States, 79701-5946
        • Pfizer Investigational Site
      • Round Rock, Texas, United States, 78665
        • Pfizer Investigational Site
      • Round Rock, Texas, United States, 78681
        • Pfizer Investigational Site
      • Round Rock, Texas, United States, 78745
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78258
        • Pfizer Investigational Site
      • San Marcos, Texas, United States, 78666
        • Pfizer Investigational Site
      • Shenandoah, Texas, United States, 77384
        • Pfizer Investigational Site
      • Tyler, Texas, United States, 75702
        • Pfizer Investigational Site
      • Waco, Texas, United States, 76712
        • Pfizer Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403-3274
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Pfizer Investigational Site
      • Christiansburg, Virginia, United States, 24073
        • Pfizer Investigational Site
      • Fairfax, Virginia, United States, 22031
        • Pfizer Investigational Site
      • Leesburg, Virginia, United States, 20176
        • Pfizer Investigational Site
      • Norton, Virginia, United States, 24273
        • Pfizer Investigational Site
      • Roanoke, Virginia, United States, 24014
        • Pfizer Investigational Site
      • Salem, Virginia, United States, 24153
        • Pfizer Investigational Site
      • Woodbridge, Virginia, United States, 22191
        • Pfizer Investigational Site
      • Wytheville, Virginia, United States, 24382
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, United States, 98003
        • Pfizer Investigational Site
      • Kennewick, Washington, United States, 99336
        • Pfizer Investigational Site
      • Lakewood, Washington, United States, 98499
        • Pfizer Investigational Site
      • Moses Lake, Washington, United States, 98837
        • Pfizer Investigational Site
      • Puyallup, Washington, United States, 98372
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
      • Vancouver, Washington, United States, 98684
        • Pfizer Investigational Site
      • Vancouver, Washington, United States, 98686
        • Pfizer Investigational Site
      • Wenatchee, Washington, United States, 98801
        • Pfizer Investigational Site
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Pfizer Investigational Site
      • Morgantown, West Virginia, United States, 26506
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: paclitaxel
Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
Drug: bevacizumab
Bevacizumab 10 mg/kg IV every 2 weeks.
Other Names:
  • Avastin
Experimental: A
Drug: Sunitinib
Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
Other Names:
  • SU011248, Sutent
Drug: paclitaxel
Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Objective Response
Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months
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.
From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months
Duration of Response (DR)
Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause
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.
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)
Time Frame: From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.
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.
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
Time Frame: Year 1, Year 2
Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.
Year 1, Year 2
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
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.
Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
EORTC QLQ Breast Cancer Module (BR23)
Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
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.
Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
Euro Quality of Life-5 Dimension (EQ-5D)
Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
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.
Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
EQ - Visual Analog Scale (EQ-VAS)
Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
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.
Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months
Biomarkers
Time Frame: Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1
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.
Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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