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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00229697 |
This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.
Condition | Intervention | Phase |
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Breast Neoplasms |
Drug: Gefitinib Drug: Tamoxifen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours |
Enrollment: | 274 |
Study Start Date: | October 2003 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Iressa Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | 1839IL/0225, D7917C00225 |
Study First Received: | September 28, 2005 |
Last Updated: | June 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00229697 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Breast cancer metastatic breast cancer |
Estrogen Antagonists Estrogens Skin Diseases Progesterone Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Protein Kinase Inhibitors Tamoxifen Hormones Estrogen Receptor Modulators Gefitinib Breast Diseases |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Enzyme Inhibitors Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Protein Kinase Inhibitors Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Gefitinib Breast Diseases |