- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00357110
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer (@FAME)
December 3, 2010 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Feldkirch, Austria
- Research Site
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Graz, Austria
- Research Site
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Innsbruck, Austria
- Research Site
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Klagenfurt, Austria
- Research Site
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Leoben, Austria
- Research Site
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Linz, Austria
- Research Site
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Salzburg, Austria
- Research Site
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St. Veit, Austria
- Research Site
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Wien, Austria
- Research Site
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Wiener Neustadt, Austria
- Research Site
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Bayreuth, Germany
- Research Site
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Essen, Germany
- Research Site
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Hamburg-Eppendorf, Germany
- Research Site
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Heidelberg, Germany
- Research Site
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Munich, Germany
- Research Site
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Rostock, Germany
- Research Site
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Tubingen, Germany
- Research Site
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Drammen, Norway
- Research Site
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Fredrikstad, Norway
- Research Site
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Kristiansand, Norway
- Research Site
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Oslo, Norway
- Research Site
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Porsgrunn, Norway
- Research Site
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Stavanger, Norway
- Research Site
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Tonsberg, Norway
- Research Site
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Trondheim, Norway
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 2
Anastrozole + Fulvestrant
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intramuscular injection
Other Names:
1 mg oral tablet
Other Names:
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Active Comparator: 1
Anastrozole monotherapy
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1 mg oral tablet
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
Time Frame: 12 month period following randomisation
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Number of patients event-free
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12 month period following randomisation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Breast Cancer Established Brands Team Medical Science Director, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
July 20, 2006
First Submitted That Met QC Criteria
July 26, 2006
First Posted (Estimate)
July 27, 2006
Study Record Updates
Last Update Posted (Estimate)
December 21, 2010
Last Update Submitted That Met QC Criteria
December 3, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Fulvestrant
- Anastrozole
Other Study ID Numbers
- D6990C00001
- ABCSG21
- Eudract No 2005-005715-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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