Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
ARNO-95
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.
2 other identifiers
interventional
1,059
1 country
43
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Nov 1996
Longer than P75 for phase_2 breast-cancer
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedJune 9, 2009
June 1, 2009
February 6, 2006
June 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (3)
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
Study Arms (2)
1
EXPERIMENTALAnastrozole
2
ACTIVE COMPARATORTamoxifen
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
- or more tumour-infiltrated lymph nodes.
- serious accompanying diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- German Adjuvant Breast Cancer Groupcollaborator
Study Sites (43)
Research Site
Albstadt, Germany
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Berlin, Germany
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Cloppenburg, Germany
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Eggenfelden, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Göttingen, Germany
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Halle, Germany
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Hamburg, Germany
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Hanau, Germany
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Hanover, 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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Lübeck, Germany
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Magdeburg, Germany
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Mainz, Germany
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Mannheim, Germany
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München, Germany
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Münster, Germany
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Neustadt, Germany
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Osnabrück, 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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Rüsselsheim am Main, Germany
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Schleswig, Germany
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Siegen, Germany
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Titisee-Neustadt, Germany
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Tübingen, 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
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Würzburg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Kaufmann, MD
German Adjuvant Breast Cancer Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
November 1, 1996
Study Completion
September 1, 2004
Last Updated
June 9, 2009
Record last verified: 2009-06