E3 Breast Cancer Taxotere Combination

Genzyme, a Sanofi Company64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Advanced Breast Cancer

Interventions

Vandetanib (ZD6474)DRUG

once daily oral dose

DocetaxelDRUG

intravenous infusion

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Research Site

Budapest, Hungary

Research Site

Pécs, Hungary

Research SIte

Bloemfontein, South Africa

Research Site

Cape Town, South Africa

Outcomes

Primary Outcomes

Number of Patients With a Disease Progression Event

Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

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

Data from ClinicalTrials.gov

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