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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00287534
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : June 9, 2009
German Adjuvant Breast Cancer Group
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole Drug: Tamoxifen Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1059 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 1996
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Anastrozole
Other Names:
  • Arimidex
  • ZD1033
Active Comparator: 2
Drug: Tamoxifen
Other Name: Nolvadex

Primary Outcome Measures :
  1. 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 :
  1. To assess difference in overall survival between the two treatment arms
  2. To assess difference in disease recurrence between the two treatment arms
  3. To assess difference in safety and tolerability between the two treatment arms

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287534

Research Site
Albstadt, Germany
Research Site
Berlin, Germany
Research Site
Cloppenburg, Germany
Research Site
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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Magdeburg, 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
Research Site
Wuerzburg, Germany
Sponsors and Collaborators
German Adjuvant Breast Cancer Group
Principal Investigator: Manfred Kaufmann, MD German Adjuvant Breast Cancer Group

ClinicalTrials.gov Identifier: NCT00287534     History of Changes
Other Study ID Numbers: 1033GR/0001
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: June 9, 2009
Last Verified: June 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