Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00357110

Purpose

Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: Fulvestrant Drug: Anastrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Frequency of events (Disseminated Tumour Cells present in bone marrow samples) [ Time Frame: after 12 months of randomised treatment ] [ Designated as safety issue: No ]
Clinical recurrence and/or death [ Time Frame: after 12 months of randomised treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency of adverse events [ Time Frame: after 12 and 24 months of randomised treatment ] [ Designated as safety issue: Yes ]

Enrollment:	13
Study Start Date:	April 2006
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Active Comparator Anastrozole monotherapy	Drug: Anastrozole 1 mg oral tablet
2: Experimental Anastrozole + Fulvestrant	Drug: Fulvestrant intramuscular injection Drug: Anastrozole 1 mg oral tablet

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation

Exclusion Criteria:

Inflammatory and/or metastatic breast cancer.
Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).
History of bleeding diathesis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357110

Locations

Austria
Research Site
Innsbruck, Austria
Research Site
St. Veit, Austria
Research Site
Wien, Austria
Research Site
Wiener Neustadt, Austria
Research Site
Linz, Austria
Research Site
Salzburg, Austria
Research Site
Graz, Austria
Research Site
Klagenfurt, Austria
Research Site
Feldkirch, Austria
Research Site
Leoben, Austria
Germany
Research Site
Munich, Germany
Research Site
Essen, Germany
Research Site
Rostock, Germany
Research Site
Tubingen, Germany
Research Site
Heidelberg, Germany
Research Site
Hamburg-Eppendorf, Germany
Research Site
Bayreuth, Germany
Norway
Research Site
Oslo, Norway
Research Site
Kristiansand, Norway
Research Site
Stavanger, Norway
Research Site
Tonsberg, Norway
Research Site
Trondheim, Norway
Research Site
Drammen, Norway
Research SIte
Porsgrunn, Norway
Research Site
Fredrikstad, Norway

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Breast Cancer Established Brands Team Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	D6990C00001, ABCSG21, Eudract No 2005-005715-22
Study First Received:	July 20, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00357110
Health Authority:	Austria: Federal Ministry for Health and Women; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:

Breast neoplasms
breast cancer
early breast cancer
oncology

cancer
breast cancer micrometastasis
fulvestrant

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Fulvestrant
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009