Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

Breast Cancer Clinical Trial

— ARNO-95  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287534
• Other study ID #: 1033GR/0001
• Secondary ID: ARNO-95
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2006
• Last updated: June 7, 2009
• Start date: November 1996
• Est. completion date: September 2004

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1059
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
oral
• Tamoxifen
oral

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	German Adjuvant Breast Cancer Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess difference in overall survival between the two treatment arms
Secondary	To assess difference in disease recurrence between the two treatment arms
Secondary	To assess difference in safety and tolerability between the two treatment arms