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Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. (ARNO-95)

This study has been completed.
German Adjuvant Breast Cancer Group
Information provided by:
AstraZeneca Identifier:
First received: February 6, 2006
Last updated: June 7, 2009
Last verified: June 2009
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 to receive tamoxifen

Secondary Outcome Measures:
  • To assess difference in overall survival between the two treatment arms
  • To assess difference in disease recurrence between the two treatment arms
  • To assess difference in safety and tolerability between the two treatment arms

Estimated Enrollment: 1059
Study Start Date: November 1996
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: 1
Drug: Anastrozole
Other Names:
  • Arimidex
  • ZD1033
Active Comparator: 2
Drug: Tamoxifen
Other Name: Nolvadex


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent,
  • Post-menopausal women ≤75 years,
  • histologically confirmed invasive breast carcinoma (no distant metastases),
  • positive hormone receptor status,
  • continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery

Exclusion Criteria:

  • menopause status maintained by medication,
  • pre-operative chemotherapy or hormone therapy or radiation therapy,
  • relapse or second carcinoma or previous cancerous disease,
  • breast carcinoma in situ,
  • simultaneous carcinoma of the opposite side or secondary breast,
  • 10 or more tumour-infiltrated lymph nodes.
  • serious accompanying diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00287534

Research Site
Albstadt, Germany
Research Site
Berlin, Germany
Research Site
Cloppenburg, Germany
Research Site
Eggenfelden, Germany
Research Site
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
Research Site
Magdeburg, Germany
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Mainz, Germany
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Mannheim, Germany
Research Site
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
Research Site
Rosenheim, Germany
Research Site
Rostock, Germany
Research Site
Ruesselsheim, Germany
Research Site
Schleswig, Germany
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Siegen, Germany
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Titisee-Neustadt, Germany
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Tuebingen, Germany
Research Site
Ulm, Germany
Research Site
Waiblingen, Germany
Research Site
Westerstede, Germany
Research Site
Worms, Germany
Research Site
Wuerzburg, Germany
Sponsors and Collaborators
German Adjuvant Breast Cancer Group
Principal Investigator: Manfred Kaufmann, MD German Adjuvant Breast Cancer Group
  More Information Identifier: NCT00287534     History of Changes
Other Study ID Numbers: 1033GR/0001
Study First Received: February 6, 2006
Last Updated: June 7, 2009

Keywords provided by AstraZeneca:
Early Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017