Clinical trial NCT00784888: Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy
Official title: A Non-Interventional Study Evaluating The Effects Of Aromatase Inhibitor Treatment After 2-3 Years Tamoxifen - As Adjuvant Endocrine Therapy - On Quality Of Life And Safety In Endocrine Responsive Early Stage Postmenopausal Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: aromatase inhibitor
quality of life
safety
postmenopausal breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 344
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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.

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.

Primary outcomes:
measure: 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)
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Bursa
country: Turkey
facility: Pfizer Investigational Site
city: Denizli
country: Turkey
facility: Pfizer Investigational Site
city: Edirne
country: Turkey
facility: Pfizer Investigational Site
city: Erzurum
country: Turkey
facility: Pfizer Investigational Site
city: Gaziantep
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Kocaeli
country: Turkey
facility: Pfizer Investigational Site
city: Malatya
country: Turkey
facility: Pfizer Investigational Site
city: Trabzon
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: