Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
German Adjuvant Breast Cancer Group
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00287534
First received: February 6, 2006
Last updated: June 7, 2009
Last verified: June 2009
  Purpose

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
Endpoint Classification: Efficacy Study
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
Anastrozole
Drug: Anastrozole
oral
Other Names:
  • Arimidex
  • ZD1033
Active Comparator: 2
Tamoxifen
Drug: Tamoxifen
oral
Other Name: Nolvadex

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00287534

Locations
Germany
Research Site
Albstadt, Germany
Research Site
Berlin, Germany
Research Site
Cloppenburg, Germany
Research Site
Eggenfelden, Germany
Research Site
Frankfurt, Germany
Research Site
Freiburg, Germany
Research Site
Goettingen, Germany
Research Site
Halle, Germany
Research Site
Hamburg, Germany
Research Site
Hanau, Germany
Research Site
Hannover, Germany
Research Site
Heidelberg, Germany
Research Site
Hoyerswerda, Germany
Research Site
Idar-Oberstein, Germany
Research Site
Jena, Germany
Research Site
Karlsruhe, Germany
Research Site
Kassel, Germany
Research Site
Kiel, Germany
Research Site
Leonberg, Germany
Research Site
Lingen, Germany
Research Site
Luebeck, Germany
Research Site
Magdeburg, Germany
Research Site
Mainz, Germany
Research Site
Mannheim, Germany
Research Site
Muenchen, Germany
Research Site
Muenster, Germany
Research Site
Neustadt, Germany
Research Site
Osnabrueck, Germany
Research Site
Paderborn, Germany
Research Site
Pforzheim, Germany
Research Site
Recklinghausen, Germany
Research Site
Rosenheim, Germany
Research Site
Rostock, Germany
Research Site
Ruesselsheim, Germany
Research Site
Schleswig, Germany
Research Site
Siegen, Germany
Research Site
Titisee-Neustadt, Germany
Research Site
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
AstraZeneca
German Adjuvant Breast Cancer Group
Investigators
Principal Investigator: Manfred Kaufmann, MD German Adjuvant Breast Cancer Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00287534     History of Changes
Other Study ID Numbers: 1033GR/0001, ARNO-95
Study First Received: February 6, 2006
Last Updated: June 7, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Early Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anastrozole
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014