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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00357110
First received: July 20, 2006
Last updated: December 3, 2010
Last verified: December 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

  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
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
Wien, Austria
Research Site
Wiener Neustadt, Austria
Germany
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
Norway
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
AstraZeneca
Investigators
Study Director: Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00357110     History of Changes
Other Study ID Numbers: D6990C00001, ABCSG21, Eudract No 2005-005715-22
Study First Received: July 20, 2006
Results First Received: December 18, 2009
Last Updated: December 3, 2010
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013