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Sponsors and Collaborators: |
AstraZeneca Institute of Cancer Research, United Kingdom |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00286117 |
The purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Anastrozole Drug: Tamoxifen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years |
Enrollment: | 448 |
Study Start Date: | March 1998 |
Study Completion Date: | May 2006 |
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
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Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Research Site | |
Chieti, Italy | |
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Catania, Italy | |
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Ferrara, Italy | |
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Genova, Italy | |
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Lugo, Italy | |
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Messina, Italy | |
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Terni, Italy | |
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Palermo, Italy | |
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Arezzo, Italy | |
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Monserrato, Italy | |
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Firenze, Italy | |
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Forli, Italy | |
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Rovigo, Italy | |
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San Remo, Italy | |
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Saronno, Italy | |
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Sassari, Italy | |
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Torino, Italy | |
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Trieste, Italy | |
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Roma, Italy | |
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Milano, Italy | |
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Casalpusterlengo, Italy | |
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Pinerolo, Italy | |
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Bologna, Italy | |
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Vicenza, Italy | |
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Pavia, Italy |
Study Director: | AstraZeneca Arimidex Medical Science Director, MD | AstraZeneca |
Principal Investigator: | Francesco Boccardo, MD | University and National Cancer Research Institute |
Responsible Party: | AstraZeneca ( Francisco Sapunar, MD - Arimidex Medical Science Director ) |
Study ID Numbers: | 1033IT/0002, ITA |
Study First Received: | February 2, 2006 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00286117 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
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 Estrogen Receptor Modulators Aromatase Inhibitors Breast Diseases Menopause |
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 |