A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

September 25, 2008 updated by: Pfizer

A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)

The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1549

Phase

  • Phase 4

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

  • Belgium
      • Aalst, Belgium, 9300
        • Pfizer Investigational Site
      • Antwerpen, Belgium, 2020
        • Pfizer Investigational Site
      • Arlon, Belgium, 6700
        • Pfizer Investigational Site
      • Baudour, Belgium, 7331
        • Pfizer Investigational Site
      • Bonheiden, Belgium, 2820
        • Pfizer Investigational Site
      • Bouge, Belgium, 5004
        • Pfizer Investigational Site
      • Boussu, Belgium, 7300
        • Pfizer Investigational Site
      • Braine-l'Alleud, Belgium, 1420
        • Pfizer Investigational Site
      • Brasschaat, Belgium, 2930
        • Pfizer Investigational Site
      • Brugge, Belgium, 8000
        • Pfizer Investigational Site
      • Brussel, Belgium, 1000
        • Pfizer Investigational Site
      • Brussels, Belgium, 1070
        • Pfizer Investigational Site
      • Brussels, Belgium, 1020
        • Pfizer Investigational Site
      • Brussels, Belgium, 1000
        • Pfizer Investigational Site
      • Brussels, Belgium, 1200
        • Pfizer Investigational Site
      • Brussels, Belgium, B-1040
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1050
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1180
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1040
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1210
        • Pfizer Investigational Site
      • Charleroi, Belgium, 6000
        • Pfizer Investigational Site
      • Chenee, Belgium, 4032
        • Pfizer Investigational Site
      • Chimay, Belgium, 6460
        • Pfizer Investigational Site
      • Dendermonde, Belgium, 9200
        • Pfizer Investigational Site
      • Duffel, Belgium, 2570
        • Pfizer Investigational Site
      • Edegem, Belgium, 2650
        • Pfizer Investigational Site
      • Eupen, Belgium, 4700
        • Pfizer Investigational Site
      • Genk, Belgium, 3600
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Gilly (Charleroi), Belgium, 6060
        • Pfizer Investigational Site
      • Gosselies, Belgium, 6041
        • Pfizer Investigational Site
      • Halle, Belgium, 1500
        • Pfizer Investigational Site
      • Hasselt, Belgium, 3500
        • Pfizer Investigational Site
      • Herstal, Belgium, 4040
        • Pfizer Investigational Site
      • Hornu, Belgium, 7301
        • Pfizer Investigational Site
      • Huy, Belgium, 4500
        • Pfizer Investigational Site
      • Kortrijk, Belgium, 8500
        • Pfizer Investigational Site
      • La Louviere, Belgium, 7100
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Libramont, Belgium, 6800
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
      • Lier, Belgium, 2500
        • Pfizer Investigational Site
      • Liège, Belgium, 4000
        • Pfizer Investigational Site
      • Mechelen, Belgium, 2800
        • Pfizer Investigational Site
      • Merksem, Belgium, 2170
        • Pfizer Investigational Site
      • Mons, Belgium, 7000
        • Pfizer Investigational Site
      • Montigny-le-Tilleul, Belgium, 6110
        • Pfizer Investigational Site
      • Mouscron, Belgium, 7700
        • Pfizer Investigational Site
      • Namur, Belgium, 5000
        • Pfizer Investigational Site
      • Ottignies, Belgium, 1340
        • Pfizer Investigational Site
      • Rocourt, Belgium, 4000
        • Pfizer Investigational Site
      • Roeselare, Belgium, 8800
        • Pfizer Investigational Site
      • Seraing, Belgium, 4100
        • Pfizer Investigational Site
      • Sint-Niklaas, Belgium, 9100
        • Pfizer Investigational Site
      • Soignies, Belgium, 7060
        • Pfizer Investigational Site
      • Tongeren, Belgium, 3700
        • Pfizer Investigational Site
      • Torhout, Belgium, 8820
        • Pfizer Investigational Site
      • Tournai, Belgium, 7500
        • Pfizer Investigational Site
      • Turnhout, Belgium, 2300
        • Pfizer Investigational Site
      • Verviers, Belgium, 4800
        • Pfizer Investigational Site
      • Waregem, Belgium, 8790
        • Pfizer Investigational Site
      • Wilrijk, Belgium, 2610
        • Pfizer Investigational Site
      • Yvoir, Belgium, 5530
        • Pfizer Investigational 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 patients
  • Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
  • Estrogen receptor positive breast cancer patients
  • Patients who remain free from disease following treatment with tamoxifen

Exclusion Criteria:

  • Patients taking other drugs for the adjuvant treatment of breast cancer
  • Patients taking hormone replacement therapy
  • Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exemestane group
Drug: exemestane
Exemestane 25 mg oral tablet once daily for a maximum of 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess for serious adverse events
Time Frame: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment
Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety Surveillance Program
Time Frame: Duration of trial
Duration of trial

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

September 29, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5991077

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.

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