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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00649090

Enrollment

1549

Registered

2008-04-01

Start date

2005-03-31

Completion date

2007-04-30

Last updated

2008-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

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 and to collect all serious adverse events.

Interventions

DRUGexemestane

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety Surveillance Program	Duration of trial

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026