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

June 7, 2009 updated by: AstraZeneca

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1059

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Tamoxifen
Drug: Tamoxifen
oral
Other Names:
  • Nolvadex
Experimental: 1
Anastrozole
Drug: Anastrozole
oral
Other Names:
  • ZD1033
  • Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

German Adjuvant Breast Cancer Group

Investigators

  • Principal Investigator: Manfred Kaufmann, MD, German Adjuvant Breast Cancer Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

June 9, 2009

Last Update Submitted That Met QC Criteria

June 7, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1033GR/0001
  • ARNO-95

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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