E3 Breast Cancer Taxotere Combination

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494481
First received: June 28, 2007
Last updated: April 27, 2011
Last verified: April 2011
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Advanced Breast Cancer
Interventions: Drug: Vandetanib (ZD6474)
Drug: Docetaxel

  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
First patient randomised 03 February 2006, last patient randomised 25 April 2007, data cut off data 23 June 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vandetanib Plus Docetaxel vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel placebo plus docetaxel

Participant Flow:   Overall Study
    Vandetanib Plus Docetaxel     Placebo Plus Docetaxel  
STARTED     35 [1]   29 [1]
COMPLETED     6 [2]   5 [2]
NOT COMPLETED     29     24  
Condition under investigation worsened                 11                 13  
Adverse Event                 15                 11  
Other                 1                 0  
Never received IP                 2                 0  
[1] randomised patients
[2] ongoing study treatment at data cut-off



  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
Vandetanib Plus Docetaxel vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel placebo plus docetaxel
Total Total of all reporting groups

Baseline Measures
    Vandetanib Plus Docetaxel     Placebo Plus Docetaxel     Total  
Number of Participants  
[units: participants]
  35     29     64  
Age  
[units: Years]
Mean ( Full Range )
  54  
  ( 33 to 80 )  
  57  
  ( 39 to 74 )  
  55.5  
  ( 33 to 80 )  
Gender  
[units: Participants]
     
Female     35     29     64  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Number of Patients With a Disease Progression Event   [ Time Frame: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off ]


  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
No text entered.


  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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: MSD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00494481     History of Changes
Other Study ID Numbers: D4200C00046
Study First Received: June 28, 2007
Results First Received: April 27, 2011
Last Updated: April 27, 2011
Health Authority: South Africa: Medicines Control Council
Taiwan: Department of Health
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy
Spain: Spanish Agency of Medicines