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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00357110 |
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Fulvestrant Drug: Anastrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow |
Enrollment: | 13 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
Anastrozole monotherapy
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Drug: Anastrozole
1 mg oral tablet
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2: Experimental
Anastrozole + Fulvestrant
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Drug: Fulvestrant
intramuscular injection
Drug: Anastrozole
1 mg oral tablet
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Research Site | |
Innsbruck, Austria | |
Research Site | |
St. Veit, Austria | |
Research Site | |
Wien, Austria | |
Research Site | |
Wiener Neustadt, Austria | |
Research Site | |
Linz, Austria | |
Research Site | |
Salzburg, Austria | |
Research Site | |
Graz, Austria | |
Research Site | |
Klagenfurt, Austria | |
Research Site | |
Feldkirch, Austria | |
Research Site | |
Leoben, Austria | |
Germany | |
Research Site | |
Munich, Germany | |
Research Site | |
Essen, Germany | |
Research Site | |
Rostock, Germany | |
Research Site | |
Tubingen, Germany | |
Research Site | |
Heidelberg, Germany | |
Research Site | |
Hamburg-Eppendorf, Germany | |
Research Site | |
Bayreuth, Germany | |
Norway | |
Research Site | |
Oslo, Norway | |
Research Site | |
Kristiansand, Norway | |
Research Site | |
Stavanger, Norway | |
Research Site | |
Tonsberg, Norway | |
Research Site | |
Trondheim, Norway | |
Research Site | |
Drammen, Norway | |
Research SIte | |
Porsgrunn, Norway | |
Research Site | |
Fredrikstad, Norway |
Study Director: | Breast Cancer Established Brands Team Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D6990C00001, ABCSG21, Eudract No 2005-005715-22 |
Study First Received: | July 20, 2006 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00357110 |
Health Authority: | Austria: Federal Ministry for Health and Women; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency |
Breast neoplasms breast cancer early breast cancer oncology |
cancer breast cancer micrometastasis fulvestrant |
Anastrozole Skin Diseases Fulvestrant Breast Neoplasms Breast Diseases |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |