E3 Breast Cancer Taxotere Combination

NCT ID: NCT00494481

Last Updated: 2016-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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Conditions

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Advanced Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Docetaxel + placebo vandetanib

Group Type PLACEBO_COMPARATOR

Docetaxel

Intervention Type DRUG

intravenous infusion

2

Vandetanib + Docetaxel

Group Type EXPERIMENTAL

Vandetanib (ZD6474)

Intervention Type DRUG

once daily oral dose

Docetaxel

Intervention Type DRUG

intravenous infusion

Interventions

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Vandetanib (ZD6474)

once daily oral dose

Intervention Type DRUG

Docetaxel

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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ZACTIMA™ Taxotere®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Research Site

Budapest, , Hungary

Site Status

Research Site

Pécs, , Hungary

Site Status

Research SIte

Bloemfontein, , South Africa

Site Status

Research Site

Cape Town, , South Africa

Site Status

Research Site

Observatory, , South Africa

Site Status

Research Site

Barakaldo, , Spain

Site Status

Research SIte

Lleida, , Spain

Site Status

Research Site

Zaragoza, , Spain

Site Status

Research Site

Umeå, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Research Site

Västerås, , Sweden

Site Status

Research Site

Taipei, , Taiwan

Site Status

Countries

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Hungary South Africa Spain Sweden Taiwan

Other Identifiers

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2005-003592-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D4200C00046

Identifier Type: -

Identifier Source: org_study_id

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