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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 20, 2006
Last updated: December 3, 2010
Last verified: December 2010
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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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

Enrollment: 13
Study Start Date: April 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Research Site
Salzburg, Austria
Research Site
St. Veit, Austria
Research Site
Wiener Neustadt, Austria
Research Site
Wien, Austria
Research Site
Bayreuth, Germany
Research Site
Essen, Germany
Research Site
Hamburg-Eppendorf, Germany
Research Site
Heidelberg, Germany
Research Site
Munich, Germany
Research Site
Rostock, Germany
Research Site
Tubingen, Germany
Research Site
Drammen, Norway
Research Site
Fredrikstad, Norway
Research Site
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
  More Information Identifier: NCT00357110     History of Changes
Other Study ID Numbers: D6990C00001
Eudract No 2005-005715-22
Study First Received: July 20, 2006
Results First Received: December 18, 2009
Last Updated: December 3, 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 processed this record on August 22, 2017