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

This study has been completed.

First Received on February 2, 2006. Last Updated on April 30, 2009 History of Changes

Sponsor:	AstraZeneca
Collaborator:	Institute of Cancer Research, United Kingdom
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00286117

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Anastrozole Drug: Tamoxifen	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause

Drug Information available for: Tamoxifen Tamoxifen citrate Anastrozole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	448
Study Start Date:	March 1998
Study Completion Date:	May 2006

Arms	Assigned Interventions
Experimental: 1 Anastrozole	Drug: Anastrozole oral Other Names: Arimidex ZD1033
Active Comparator: 2 Tamoxifen	Drug: Tamoxifen oral Other Name: Nolvadex

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286117

Locations

Italy
Research Site
Arezzo, Italy
Research Site
Bologna, Italy
Research Site
Casalpusterlengo, Italy
Research Site
Catania, Italy
Research Site
Chieti, Italy
Research Site
Ferrara, Italy
Research Site
Firenze, Italy
Research Site
Forli, Italy
Research Site
Genova, Italy
Research Site
Lugo, Italy
Research Site
Messina, Italy
Research Site
Milano, Italy
Research Site
Monserrato, Italy
Research Site
Palermo, Italy
Research Site
Pavia, Italy
Research Site
Pinerolo, Italy
Research Site
Roma, Italy
Research Site
Rovigo, Italy
Research Site
San Remo, Italy
Research Site
Saronno, Italy
Research Site
Sassari, Italy
Research Site
Terni, Italy
Research Site
Torino, Italy
Research Site
Trieste, Italy
Research Site
Vicenza, Italy

Sponsors and Collaborators

AstraZeneca

Institute of Cancer Research, United Kingdom

Investigators

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

More Information

No publications provided

Responsible Party:	Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00286117 History of Changes
Other Study ID Numbers:	1033IT/0002, ITA
Study First Received:	February 2, 2006
Last Updated:	April 30, 2009
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by AstraZeneca:

Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012