Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer (SUN 1064)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00393939
First received: October 30, 2006
Last updated: July 13, 2012
Last verified: July 2012
Results First Received: January 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: Sunitinib malate
Drug: Taxotere

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
594 participants enrolled in study; 1 participant withdrew consent prior to treatment. In accordance with French law, that participant's data was not used in the analyses.

Reporting Groups
  Description
Docetaxel + Sunitinib Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
Docetaxel Docetaxel 100 mg/m^2 every 3 weeks

Participant Flow:   Overall Study
    Docetaxel + Sunitinib     Docetaxel  
STARTED     296     297  
Treated     295     293  
COMPLETED     0     0  
NOT COMPLETED     296     297  
Protocol Violation                 1                 1  
Lost to Follow-up                 2                 4  
Death                 10                 4  
Sponsor                 5                 13  
Objective progression or relapse                 239                 223  
Withdrawal by Subject                 2                 7  
Not specified                 37                 45  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Docetaxel + Sunitinib Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
Docetaxel Docetaxel 100 mg/m^2 every 3 weeks
Total Total of all reporting groups

Baseline Measures
    Docetaxel + Sunitinib     Docetaxel     Total  
Number of Participants  
[units: participants]
  296     297     593  
Age  
[units: Years]
Mean ± Standard Deviation
  54.3  ± 9.74     55.1  ± 10.36     54.7  ± 10.05  
Gender  
[units: Participants]
     
Female     296     297     593  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline up to Month 33 ]

2.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: Baseline up to Month 33 ]

3.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline up to Month 33 ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline to date of death from any cause (up to Month 33) ]

5.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score   [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]

6.  Secondary:   Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score   [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]

7.  Secondary:   Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score   [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00393939     History of Changes
Other Study ID Numbers: A6181064
Study First Received: October 30, 2006
Results First Received: January 31, 2011
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration