This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

E3 Breast Cancer Taxotere Combination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00494481
First received: June 28, 2007
Last updated: August 24, 2016
Last verified: August 2016
  Purpose
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: Double Blind (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®

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494481

Locations
Hungary
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
Spain
Research Site
Baracaldo, Spain
Research SIte
Lérida, Spain
Research Site
Zaragoza, Spain
Sweden
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
Research Site
Västerås, Sweden
Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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 )
Study First Received: June 28, 2007
Results First Received: April 27, 2011
Last Updated: August 24, 2016

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

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

ClinicalTrials.gov processed this record on July 25, 2017