3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer

This study has been completed.

First Received on March 7, 2006. Last Updated on April 30, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00300508

Purpose

The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.

Condition	Intervention	Phase
Breast Neoplasms	Drug: Anastrozole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Recurrence-free and overall survival

Secondary Outcome Measures:

Secondary cancers

Estimated Enrollment:	856
Study Start Date:	January 1996

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

No disease recurrence at time of randomization,
patients with breast cancer after surgery,
5 years (+/- 12 months) of prior endocrine therapy

Exclusion Criteria:

Premenopausal patients,
unknown or negative receptor status,
Secondary malignant tumor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300508

Show 52 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Austria Medical Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00300508 History of Changes
Other Study ID Numbers:	1033AU/0001, ABCSG 6A
Study First Received:	March 7, 2006
Last Updated:	April 30, 2009
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by AstraZeneca:

Hormone receptor positive breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012