Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Breast Neoplasms

Eligibility:

FEMALE

Phase:

PHASE4

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2007

Estimated Enrollment :

1549 Patients enrolled

Trial Details

Trial ID

NCT00649090

Start Date

March 1 2005

End Date

April 1 2007

Last Update

September 29 2008

Active Locations (61)

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Page 1 of 16 (61 locations)

1

Pfizer Investigational Site

Aalst, Belgium, 9300

2

Pfizer Investigational Site

Antwerp, Belgium, 2020

3

Pfizer Investigational Site

Arlon, Belgium, 6700

4

Pfizer Investigational Site

Baudour, Belgium, 7331