Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment
1. TOI is the sum of the scores from the physical and functional well-being and the breast
cancer subscales.
2. To assess incidence of adverse events (including cardiovascular, cerebrovascular, and
endocrine, musculoskeletal) in Korean postmenopausal breast cancer patients in early
adjuvant setting.
3. To assess the effect of letrozole (Femara) on BMD in early adjuvant setting.
4. To assess the effect of letrozole (Femara) on total cholesterol in early adjuvant
setting.
Observational
Observational Model: Cohort, Time Perspective: Prospective
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
3 years
Yes
Sehwan Han, MD.PhD.
Principal Investigator
Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
Korea: Food and Drug Administration
KBCSG002
NCT00913016
June 2007
June 2012
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