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

June 28, 2007
April 27, 2011
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   South Africa,   Spain,   Sweden,   Taiwan
 
NCT00494481
D4200C00046
No
MSD, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Peter Langmuir, MD AstraZeneca
AstraZeneca
April 2011

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