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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: April 27, 2006
Last updated: December 14, 2007
Last verified: December 2007
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

Condition Intervention Phase
Metastatic Breast Cancer Drug: Gefitinib Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised Phase II Study: Treatment With Daily p.o. Iressa™ (ZD1839) or Placebo in Combination With Weekly IV Infusion of Docetaxel in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective tumour response (CR + PR) per RECIST criteria

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 66
Study Start Date: June 2003
Study Completion Date: June 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00319618

Research Site
Oslo, Norway
Sponsors and Collaborators
Study Director: AstraZeneca Norway Medical Director, MD AstraZeneca
  More Information Identifier: NCT00319618     History of Changes
Other Study ID Numbers: 1839IL/0128
Study First Received: April 27, 2006
Last Updated: December 14, 2007

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017