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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00319618
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : December 18, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Gefitinib Drug: Docetaxel Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
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
Study Start Date : June 2003
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Time to progression and response duration
  2. 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

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319618

Research Site
Oslo, Norway
Sponsors and Collaborators
Study Director: AstraZeneca Norway Medical Director, MD AstraZeneca
More Information

ClinicalTrials.gov Identifier: NCT00319618     History of Changes
Other Study ID Numbers: 1839IL/0128
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 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