E3 Breast Cancer Taxotere Combination

August 24, 2016 updated by: Genzyme, a Sanofi Company

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Research Site
      • Pécs, Hungary
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Observatory, South Africa
        • Research Site
  • Spain
      • Baracaldo, Spain
        • Research Site
      • Lérida, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • Sweden
      • Umeå, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Västerås, Sweden
        • Research Site
  • Taiwan
      • Taipei, Taiwan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Docetaxel + placebo vandetanib
Drug: Docetaxel
intravenous infusion
Other Names:
  • Taxotere®
Experimental: 2
Vandetanib + Docetaxel
Drug: Docetaxel
intravenous infusion
Other Names:
  • Taxotere®
Drug: Vandetanib (ZD6474)
once daily oral dose
Other Names:
  • ZACTIMA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (Estimate)

June 29, 2007

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200C00046
  • 2005-003592-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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