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

Tracking Information

First Received Date ^ICMJE

June 28, 2007

Last Updated Date

April 27, 2011

Start Date ^ICMJE

January 2006

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00494481 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

To assess the safety and tolerability of ZD6474 in combination with docetaxel in the treatment of ABC by review of adverse events and laboratory parameters [ Time Frame: assessed at each visit ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

E3 Breast Cancer Taxotere Combination

Official Title ^ICMJE

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).

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Breast Cancer

Intervention ^ICMJE

Drug: Vandetanib (ZD6474)
once daily oral dose

Other Name: ZACTIMA™
Drug: Docetaxel
intravenous infusion

Other Name: Taxotere®

Study Arm (s)

Placebo Comparator: 1
Docetaxel + placebo vandetanib

Intervention: Drug: Docetaxel
Experimental: 2
Vandetanib + Docetaxel
Interventions:
- Drug: Vandetanib (ZD6474)
- Drug: Docetaxel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hungary, South Africa, Spain, Sweden, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00494481

Other Study ID Numbers ^ICMJE

D4200C00046

Has Data Monitoring Committee

Responsible Party

MSD, AstraZeneca Pharmaceuticals

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Peter Langmuir, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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