Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. - Full Text View

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

This study has been completed.

First Received: February 6, 2006 Last Updated: June 7, 2009 History of Changes

Sponsor:	AstraZeneca
Collaborator:	German Adjuvant Breast Cancer Group
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00287534

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Anastrozole

U.S. FDA Resources

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
1: Experimental Anastrozole	Drug: Anastrozole oral
2: Active Comparator Tamoxifen	Drug: Tamoxifen oral

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

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
Wuerzburg, 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
Magdeburg, 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

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

Keywords provided by AstraZeneca:

Early Breast Cancer

Additional relevant MeSH terms:

Estrogen Antagonists
Anastrozole
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Enzyme Inhibitors

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009