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Sponsors and Collaborators: |
AstraZeneca German Adjuvant Breast Cancer Group |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00287534 |
The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Anastrozole Drug: Tamoxifen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. |
Estimated Enrollment: | 1059 |
Study Start Date: | November 1996 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
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1: Experimental
Anastrozole
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Drug: Anastrozole
oral
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2: Active Comparator
Tamoxifen
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Drug: Tamoxifen
oral
|
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
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Albstadt, Germany | |
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Berlin, Germany | |
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Cloppenburg, Germany | |
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Eggenfelden, Germany | |
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Frankfurt, Germany | |
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Freiburg, Germany | |
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Goettingen, Germany | |
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Halle, Germany | |
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Hamburg, Germany | |
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Hanau, Germany | |
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Hannover, Germany | |
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Heidelberg, Germany | |
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Hoyerswerda, Germany | |
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Idar-Oberstein, Germany | |
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Jena, Germany | |
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Karlsruhe, Germany | |
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Kassel, Germany | |
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Kiel, Germany | |
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Leonberg, Germany | |
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Lingen, Germany | |
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Luebeck, Germany | |
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Wuerzburg, Germany | |
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Mainz, Germany | |
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Mannheim, Germany | |
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Muenchen, Germany | |
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Muenster, Germany | |
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Neustadt, Germany | |
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Osnabrueck, Germany | |
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Paderborn, Germany | |
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Pforzheim, Germany | |
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Recklinghausen, Germany | |
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Rosenheim, Germany | |
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Rostock, Germany | |
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Ruesselsheim, Germany | |
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Schleswig, Germany | |
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Siegen, Germany | |
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Titisee-Neustadt, Germany | |
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Tuebingen, Germany | |
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Ulm, Germany | |
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Waiblingen, Germany | |
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Westerstede, Germany | |
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Worms, Germany | |
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Magdeburg, Germany |
Principal Investigator: | Manfred Kaufmann, MD | German Adjuvant Breast Cancer Group |
Study ID Numbers: | 1033GR/0001, ARNO-95 |
Study First Received: | February 6, 2006 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00287534 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Early Breast Cancer |
Estrogen Antagonists Anastrozole Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Adjuvants, Immunologic Breast Neoplasms |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Hormones Carcinoma Estrogen Receptor Modulators Aromatase Inhibitors Breast Diseases |
Estrogen Antagonists Anastrozole 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 Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors Breast Diseases |