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E3 Breast Cancer Taxotere Combination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00494481
First Posted: June 29, 2007
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
June 28, 2007
June 29, 2007
April 27, 2011
May 24, 2011
September 30, 2016
January 2006
June 2007   (Final data collection date for primary outcome measure)
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 ]
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
Complete list of historical versions of study NCT00494481 on ClinicalTrials.gov Archive Site
Not Provided
To assess the safety and tolerability of ZD6474 in combination with docetaxel in the treatment of ABC by review of adverse events and laboratory parameters [ Time Frame: assessed at each visit ]
Not Provided
Not Provided
 
E3 Breast Cancer Taxotere Combination
A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Advanced Breast Cancer
  • Drug: Vandetanib (ZD6474)
    once daily oral dose
    Other Name: ZACTIMA™
  • Drug: Docetaxel
    intravenous infusion
    Other Name: Taxotere®
  • Placebo Comparator: 1
    Docetaxel + placebo vandetanib
    Intervention: Drug: Docetaxel
  • Experimental: 2
    Vandetanib + Docetaxel
    Interventions:
    • Drug: Vandetanib (ZD6474)
    • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
January 2009
June 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Females with histological/cytological confirmation of breast cancer.
  • Subjects with a measurable lesion or bone lesions

Exclusion Criteria:

  • Previous radiotherapy within 6 weeks
  • Significant cardiac events, arrhythmias or other cardiac conditions
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   South Africa,   Spain,   Sweden,   Taiwan
 
 
NCT00494481
D4200C00046
2005-003592-20 ( EudraCT Number )
No
Not Provided
Not Provided
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP