A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

June 15, 2012 updated by: Pfizer

Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated

To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

Study Type

Interventional

Enrollment (Actual)

482

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

  • Argentina
      • Buenos Aires, Argentina, C1405BCH
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1034ACO
        • Pfizer Investigational Site
      • Cordoba, Argentina, X5000AAI
        • Pfizer Investigational Site
      • Tucuman, Argentina, T4000IAK
        • Pfizer Investigational Site
    • Prov. de Buenos Aires
      • Bahia Blanca, Prov. de Buenos Aires, Argentina, B8001HXM
        • Pfizer Investigational Site
    • Rio Negro
      • Viedma, Rio Negro, Argentina, 8500
        • Pfizer Investigational Site
    • Santa Fé
      • Rosario, Santa Fé, Argentina, (2000)
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Pfizer Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Pfizer Investigational Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80530-010
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazil, 91350-200
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Brazil, 01509-900
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 01246-000
        • Pfizer Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1527
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1756
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1S 4L8
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
  • Chile
    • IX Región
      • Temuco, IX Región, Chile, 4810469
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • France
      • Bayonne, France, 64100
        • Pfizer Investigational Site
      • Besancon, France, 25030
        • Pfizer Investigational Site
      • Clermont Ferrand, France, 63011
        • Pfizer Investigational Site
      • Lille, France, 59020 Cedex
        • Pfizer Investigational Site
      • Neuilly Sur Seine, France, 92200
        • Pfizer Investigational Site
      • Nice, France, 06100
        • Pfizer Investigational Site
      • Rennes Cedex, France, 35042
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 12200
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60488
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Jena, Germany, 07743
        • Pfizer Investigational Site
      • Kiel, Germany, 24103
        • Pfizer Investigational Site
      • Leer, Germany, 26789
        • Pfizer Investigational Site
      • Luebeck, Germany, 23538
        • Pfizer Investigational Site
      • Magdeburg, Germany, 39130
        • Pfizer Investigational Site
      • Mainz, Germany, 55101
        • Pfizer Investigational Site
      • Meiningen, Germany, 98617
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
      • Offenburg, Germany, 77652
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72076
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
      • Kowloon, Hong Kong
        • Pfizer Investigational Site
      • Tuen Mun, Hong Kong
        • Pfizer Investigational Site
      • Wan Chai,, Hong Kong
        • Pfizer Investigational Site
  • India
    • Gujarat
      • Navrangpura / Ahmedabad, Gujarat, India, 380 009
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 078
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141 008
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302013
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Milano, Italy, 20162
        • Pfizer Investigational Site
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Reggio Emilia, Italy, 42100
        • Pfizer Investigational Site
  • Japan
      • Fukuoka, Japan
        • Pfizer Investigational Site
      • Osaka, Japan
        • Pfizer Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Pfizer Investigational Site
    • Ehime
      • Matsuyama-shi, Ehime, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Kitakyushu-City, Fukuoka, Japan
        • Pfizer Investigational Site
    • Osaka
      • Suita, Osaka, Japan
        • Pfizer Investigational Site
    • Saitama
      • Kita-adachi-gun, Saitama, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Chuo-Ku, Tokyo, Japan
        • Pfizer Investigational Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-717
        • Pfizer Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • Pfizer Investigational Site
      • Pusan, Korea, Republic of, 602-739
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Pfizer Investigational Site
  • Mexico
      • Chihuahua, Mexico, 31000
        • Pfizer Investigational Site
      • Puebla, Mexico, 72530
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 11000
        • Pfizer Investigational Site
    • Estado de Mexico
      • Toluca, Estado de Mexico, Mexico, 50180
        • Pfizer Investigational Site
    • Guerrero
      • Acapulco, Guerrero, Mexico, 39670
        • Pfizer Investigational Site
    • Michoacan
      • Morelia, Michoacan, Mexico, 58020
        • Pfizer Investigational Site
    • Sonora
      • Ciudad Obregon, Sonora, Mexico, 85000
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, 05127
        • Pfizer Investigational Site
      • Lima, Peru, L 27
        • Pfizer Investigational Site
  • Philippines
      • Quezon City, Philippines, 1100
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1102
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1104
        • Pfizer Investigational Site
      • San Juan City, Philippines, 1000
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Pfizer Investigational Site
      • Singapore, Singapore, 169610
        • Pfizer Investigational Site
  • South Africa
      • Parktown, South Africa, 2193
        • Pfizer Investigational Site
      • Sandton, South Africa, 2199
        • Pfizer Investigational Site
  • Spain
      • Cordoba, Spain, 14004
        • Pfizer Investigational Site
      • Gerona, Spain, 17007
        • Pfizer Investigational Site
      • Jaen, Spain, 23007
        • Pfizer Investigational Site
      • La Coruña, Spain, 15006
        • Pfizer Investigational Site
      • Las Palmas de Gran Canaria, Spain, 35016
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Madrid, Spain, 28033
        • Pfizer Investigational Site
      • Malaga, Spain, 29010
        • Pfizer Investigational Site
      • Salamanca, Spain, 37007
        • Pfizer Investigational Site
    • Barcelona
      • Mataro, Barcelona, Spain, 08304
        • Pfizer Investigational Site
      • Sabadell, Barcelona, Spain, 08208
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Pfizer Investigational Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Pfizer Investigational Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Pfizer Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 807
        • Pfizer Investigational Site
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan, 106
        • Pfizer Investigational Site
      • Taoyuan, Taiwan, 333
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34390
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
      • Nottingham, United Kingdom, NG5 1PB
        • Pfizer Investigational Site
      • Somerset, United Kingdom, BA21 4AT
        • Pfizer Investigational Site
    • South Wales
      • Cardiff, South Wales, United Kingdom, CF14 2TL
        • 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

Female

Description

Inclusion Criteria:

  • breast adenocarcinoma
  • prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria:

  • Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
  • Any prior regimen with capecitabine

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: A
1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Drug: Capecitabine
1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Other Names:
  • xeloda
Experimental: B
37.5 mg daily, continuous dosing
Drug: Sunitinib malate
37.5 mg daily, continuous dosing
Other Names:
  • sunitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or until death
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
From time of randomization to every 6 weeks thereafter through 22 months or until death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Tumor Progression (TTP)
Time Frame: From time of randomization to every 6 weeks thereafter through 22 months
Time from randomization to first documentation of objective tumor progression.
From time of randomization to every 6 weeks thereafter through 22 months
Number of Participants With Overall Response (OR)
Time Frame: From time of randomization to every 6 weeks thereafter through 22 months
OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
From time of randomization to every 6 weeks thereafter through 22 months
Duration of Response (DR)
Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or death
Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
From time of randomization to every 6 weeks thereafter through 22 months or death
Time to Tumor Response (TTR)
Time Frame: From time of randomization to every 6 weeks thereafter through 22 months
Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
From time of randomization to every 6 weeks thereafter through 22 months
Overall Survival (OS)
Time Frame: From time of randomization until death
Average time from randomization to first documentation of death due to any cause.
From time of randomization until death
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter

EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).

Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
From Day 1 of Cycle 1, then odd numbered cycles thereafter
EORTC QLQ Breast Cancer Module (BR23)
Time Frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter

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 implied a greater degree of symptoms.
From Day 1 of Cycle 1, then odd numbered cycles thereafter

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)

October 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (Estimate)

September 7, 2006

Study Record Updates

Last Update Posted (Estimate)

June 25, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181107

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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