Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer

Phase 2CompletedNCT00319618

AstraZeneca66 enrolled

Overview

The purpose of this study is to determine if combination therapy of weekly Taxotere™ with Iressa™ will increase the objective responses in measurable leasions in metastatic breast cancer

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

GefitinibDRUG

DocetaxelDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed mammary carcinoma Exclusion Criteria: * prior taxane chemotherapy for metastatic disease or prior treatment with tyrosine kinase inhibitors inhibiting the EGF receptor. * Prior hormone treatment or one type of anthracycline based treatment regimen without taxane for metastatic disease is allowed prior to inclusion. * If the patient has been treated in the adjuvant or neoadjuvant setting with taxanes, inclusion is allowed when the first cycle of trial medication is started 12 months after the last course of adjuvant treatment

Locations (1)

Research Site

Oslo, Norway

Outcomes

Primary Outcomes

Objective tumour response (CR + PR) per RECIST criteria

Secondary Outcomes

Time to progression and response duration

Exploratory outcomes: Objective tumour response in relation to ER, PgR, erb-B1 and erb-B2 receptor status and reduction in the number of malignant cells present in bone marrow

Data from ClinicalTrials.gov

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