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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Aalst, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exemestane

Drug

Exemestane 25 mg oral tablet once daily for a maximum of 3 years

Primary outcomes

Assess for serious adverse events

Time frame: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment

Secondary outcomes

Safety Surveillance Program

Time frame: Duration of trial

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Apr 1, 2008
Registry last updated: Sep 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed