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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 ] [ Designated as safety issue: No ]
    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
Genders 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
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
AstraZeneca
Investigators
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00494481     History of Changes
Other Study ID Numbers: D4200C00046
Study First Received: June 28, 2007
Results First Received: April 27, 2011
Last Updated: April 27, 2011
Health Authority: South Africa: Medicines Control Council
Taiwan: Department of Health
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Zactima

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013