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Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Mark Pegram, Stanford University
ClinicalTrials.gov Identifier:
NCT00481845
First received: May 31, 2007
Last updated: December 13, 2016
Last verified: December 2016
Results First Received: December 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Vandetanib
Drug: Anastrozole

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vandetanib + Anastrozole Vandetanib and Anastrozole as neoadjuvant therapy
Anastrozole Anastrozole as neoadjuvant therapy

Participant Flow:   Overall Study
    Vandetanib + Anastrozole   Anastrozole
STARTED   1   0 
COMPLETED   1   0 
NOT COMPLETED   0   0 



  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.
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Reporting Groups
  Description
Vandetanib + Anastrozole Vandetanib and Anastrozole as neoadjuvant therapy
Anastrozole Anastrozole as neoadjuvant therapy
Total Total of all reporting groups

Baseline Measures
   Vandetanib + Anastrozole   Anastrozole   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      1 100.0%   0      1 100.0% 
>=65 years      0   0.0%   0      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      1 100.0%   0      1 100.0% 
Male      0   0.0%   0      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%   0      0   0.0% 
Not Hispanic or Latino      1 100.0%   0      1 100.0% 
Unknown or Not Reported      0   0.0%   0      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%   0      0   0.0% 
Asian      0   0.0%   0      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%   0      0   0.0% 
Black or African American      0   0.0%   0      0   0.0% 
White      1 100.0%   0      1 100.0% 
More than one race      0   0.0%   0      0   0.0% 
Unknown or Not Reported      0   0.0%   0      0   0.0% 


  Outcome Measures
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1.  Primary:   Tumor Objective Response by MRI   [ Time Frame: 1 year ]

2.  Secondary:   Pathologic Complete Response   [ Time Frame: 1 year ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Mark Daniel Pegram; Susy Yuan-Huey Hung Professor
Organization: Stanford Cancer Institute, Stanford University
phone: 650-723-5801
e-mail: mpegram@stanford.edu



Responsible Party: Mark Pegram, Stanford University
ClinicalTrials.gov Identifier: NCT00481845     History of Changes
Other Study ID Numbers: IRB-08051
BRSADJ0008 ( Other Identifier: OnCore )
97923 ( Other Identifier: Stanford University Alternate IRB Approval Number )
Study First Received: May 31, 2007
Results First Received: December 13, 2016
Last Updated: December 13, 2016