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

This study has been completed.

Sponsored by:	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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
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.

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:	December 1995

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

AstraZeneca Clinical Study Information This link exits the ClinicalTrials.gov site

Study ID Numbers:	1033AU/0001, ABCSG 6A
Study First Received:	March 7, 2006
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00300508
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by AstraZeneca:

Hormone receptor positive breast cancer

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009