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E3 Breast Cancer Taxotere Combination

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ClinicalTrials.gov Identifier: NCT00494481
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : May 24, 2011
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: Vandetanib (ZD6474) Drug: Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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).
Study Start Date : January 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  1. 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)



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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

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


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

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