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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:
ClinicalTrials.gov Identifier:
NCT00357110
First Posted: July 27, 2006
Last Update Posted: December 21, 2010
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.
Information provided by:
AstraZeneca
  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
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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
Wiener Neustadt, Austria
Research Site
Wien, 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

ClinicalTrials.gov Identifier: NCT00357110     History of Changes
Other Study ID Numbers: D6990C00001
ABCSG21
Eudract No 2005-005715-22
First Submitted: July 20, 2006
First Posted: July 27, 2006
Results First Submitted: December 18, 2009
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
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, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action