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

Tracking Information

First Received Date ^ICMJE

February 6, 2006

Last Updated Date

June 7, 2009

Start Date ^ICMJE

November 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00287534 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Anastrozole
Drug: Tamoxifen

Study Arms / Comparison Groups

Experimental: Anastrozole
Active Comparator: Tamoxifen

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1059

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00287534

Responsible Party

Study ID Numbers ^ICMJE

1033GR/0001, ARNO-95

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

German Adjuvant Breast Cancer Group

Investigators ^ICMJE

Principal Investigator:

Manfred Kaufmann, MD

German Adjuvant Breast Cancer Group

Information Provided By

AstraZeneca

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP