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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00291759 |
The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Tamoxifen Drug: Anastrozole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years. |
Estimated Enrollment: | 3900 |
Study Start Date: | January 1996 |
Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Raimund Jakesz, MD | Austrian Breast and Colorectal Cancer Study Group |
Study Director: | AstraZeneca Austria Medical Director, MD | AstraZeneca |
Study ID Numbers: | 1033AU/0002, ABCSG 8 |
Study First Received: | February 13, 2006 |
Last Updated: | February 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00291759 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Anastrozole Skin Diseases Breast Neoplasms Tamoxifen 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 |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |