Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy

Completed

• Conditions: Breast Neoplasms
• Interventions: Other: Aromatase inhibitors

• Registration Number: NCT00784888
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to follow safety and quality of life outcomes on patients switching from tamoxifen therapy to aromatase inhibitor therapy.

Detailed Description

Group of patients using the same aromatase inhibitor

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-10-31
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 344

Inclusion Criteria

Patients with endocrine responsive early stage postmenopausal breast cancer. Patients who received tamoxifen for 2-3 years as adjuvant endocrine therapy. Patients who were approved to switch to aromatase inhibitor treatment during the patient recruitment period.

Patients who were informed about the study and accepted to participate.

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Exclusion Criteria

Patients having a psychological disorder which will prevent their understanding of questionnaires used for evaluation of quality of life and / or patients who are illiterate.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aromatase inhibitors	Aromatase inhibitors	Early stage postmenopausal breast cancer patients under tamoxifen treatment who are switching to aromatase inhibitor treatment

Primary Outcome Measures

Name	Time	Method
To evaluate the quality of life of patients with early stage postmenopausal breast cancer using aromatase inhibitor following 2-3 years of tamoxifen treatment (switch)	2 years

Secondary Outcome Measures

Name	Time	Method
To evaluate patients with early stage postmenopausal breast cancer using aromatase inhibitor following 2-3 years of tamoxifen treatment (switch) in terms of side effects	2 years

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇷 Trabzon, Turkey