Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00301457

Purpose

The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2-3 years tamoxifen

Condition	Intervention	Phase
Breast Cancer	Drug: Anastrozole	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Anastrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen [ Time Frame: Assessed after 3 years and 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the incidence of contralateral breast cancer, overall survival and toxicity after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen [ Time Frame: Assessed after 3 years and 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1900
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 6 years adjuvant anastrozole therapy	Drug: Anastrozole 1 mg once daily oral dose
2: Experimental 3 years adjuvant anastrozole therapy	Drug: Anastrozole 1 mg once daily oral dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

postmenopausal patients with hormone receptor positive breast cancer who have already received 2 to 3 years of adjuvant tamoxifen, and who never had signs of loco-regional recurrences or distant metastasis

Exclusion Criteria:

Previous hormonal therapy as adjuvant breast cancer treatment besides tamoxifen.
Previous history of invasive breast cancer within the last 10 years, other then the breast cancer that is currently treated with tamoxifen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301457

Contacts

Contact: AstraZeneca BV The Netherlands

+31 79 3632383

Show 65 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Francisco Sapunar, MD - Arimidex Medical Science Director )
Study ID Numbers:	D5392NL0003, EUDRAct No: 2005-006167-31
Study First Received:	March 9, 2006
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00301457 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Hormone Sensitive Primary Breast Cancer
Adjuvant Treatment
Aromatase Inhibitor

Study placed in the following topic categories:

Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms

Aromatase Inhibitors
Hormones
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Skin Diseases
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009