Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer (@FAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00357110
Recruitment Status : Completed
First Posted : July 27, 2006
Results First Posted : January 22, 2010
Last Update Posted : December 21, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Fulvestrant Drug: Anastrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Anastrozole monotherapy
Drug: Anastrozole
1 mg oral tablet
Other Names:
  • Arimidex
  • ZD1033
Experimental: 2
Anastrozole + Fulvestrant
Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Drug: Anastrozole
1 mg oral tablet
Other Names:
  • Arimidex
  • ZD1033

Primary Outcome Measures :
  1. 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 ]
    Number of patients event-free

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00357110

Research Site
Feldkirch, Austria
Research Site
Graz, Austria
Research Site
Innsbruck, Austria
Research Site
Klagenfurt, Austria
Research Site
Leoben, Austria
Research Site
Linz, Austria
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Salzburg, Austria
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St. Veit, Austria
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Wiener Neustadt, Austria
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Wien, Austria
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Bayreuth, Germany
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Essen, Germany
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Hamburg-Eppendorf, Germany
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Heidelberg, Germany
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Munich, Germany
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Rostock, Germany
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Tubingen, Germany
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Drammen, Norway
Research Site
Fredrikstad, Norway
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Kristiansand, Norway
Research Site
Oslo, Norway
Research SIte
Porsgrunn, Norway
Research Site
Stavanger, Norway
Research Site
Tonsberg, Norway
Research Site
Trondheim, Norway
Sponsors and Collaborators
Study Director: Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca Identifier: NCT00357110     History of Changes
Other Study ID Numbers: D6990C00001
Eudract No 2005-005715-22
First Posted: July 27, 2006    Key Record Dates
Results First Posted: January 22, 2010
Last Update Posted: December 21, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Breast neoplasms
breast cancer
early breast cancer
breast cancer micrometastasis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action