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E3 Breast Cancer Taxotere Combination

This study has been completed.
ClinicalTrials.gov Identifier:
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 )
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

Condition Intervention Phase
Advanced Breast Cancer Drug: Vandetanib (ZD6474) Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:

Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • 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)

Enrollment: 64
Study Start Date: January 2006
Study Completion Date: January 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Docetaxel + placebo vandetanib
Drug: Docetaxel
intravenous infusion
Other Name: Taxotere®
Experimental: 2
Vandetanib + Docetaxel
Drug: Vandetanib (ZD6474)
once daily oral dose
Other Name: ZACTIMA™
Drug: Docetaxel
intravenous infusion
Other Name: Taxotere®


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494481

Research Site
Budapest, Hungary
Research Site
Pécs, Hungary
South Africa
Research SIte
Bloemfontein, South Africa
Research Site
Cape Town, South Africa
Research Site
Observatory, South Africa
Research Site
Baracaldo, Spain
Research SIte
Lérida, Spain
Research Site
Zaragoza, Spain
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
Research Site
Västerås, Sweden
Research Site
Taipei, Taiwan
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00494481     History of Changes
Other Study ID Numbers: D4200C00046
2005-003592-20 ( EudraCT Number )
First Submitted: June 28, 2007
First Posted: June 29, 2007
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: September 30, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action