ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years - Tabular View

Tracking Information

First Received Date ^ICMJE

February 2, 2006

Last Updated Date

April 30, 2009

Start Date ^ICMJE

March 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary objective of this analysis was 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 on tamoxifen

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00286117 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess the difference in overall survival/disease recurrence/safety and tolerability 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 Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

Official Title ^ICMJE

An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years

Brief Summary

The purpose of this study was 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 on tamoxifen.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/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

Enrollment ^ICMJE

448

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Post-menopausal status; age ≤75 years;
histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;
oestrogen receptor status positive or unknown;
primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed

Exclusion Criteria:

Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).

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

Italy

Administrative Information

NCT ID ^ICMJE

NCT00286117

Responsible Party

Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

1033IT/0002, ITA

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Institute of Cancer Research, United Kingdom

Investigators ^ICMJE

Study Director:	AstraZeneca Arimidex Medical Science Director, MD	AstraZeneca
Principal Investigator:	Francesco Boccardo, MD	University and National Cancer Research Institute

Information Provided By

AstraZeneca

Verification Date

April 2009

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