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

  • Austria
      • 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
        • Research Site
  • Germany
      • 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
  • Norway
      • 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
        • Research Site

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

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
Number of patients event-free
12 month period following randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

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

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.

Clinical Trials on Breast Cancer

Clinical Trials on Fulvestrant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe