Overview

This trial is active, not recruiting.

Condition breast cancer
Phase phase 4
Sponsor Korean Breast Cancer Study Group
Start date June 2007
End date June 2012
Trial size 897 participants
Trial identifier NCT00913016, KBCSG002

Summary

To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B questionnaire for 3 years from baseline.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
time frame: 3 years

Eligibility Criteria

Female participants at least 45 years old.

Inclusion Criteria: 1. Patients have undergone surgery of the breast cancer and proven histologically to be breast cancer with postmenopausal women older than 45 years. Postmenopausal state was defined the following conditions, at least one of a, b, c. 1. serum FSH ≥ 30 mIU/mL 2. amenorrhea ≥ 1 year 3. oophorectomy 2. patients with estrogen receptor(+) and/or progesterone receptor(+) 3. WHO(ECOG) performance status 0-2 4. Adequate haematological function, renal function, hepatologic function. 5. No evidence of metastasis. Exclusion Criteria: 1. patient with hormone receptor negative. 2. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin. 3. Other hormone therapy given within the previous 4 weeks. 4. Patients with other aromatase inhibitor and chemotherapy 5. Uncontrolled infection, medically uncontrollable heart disease 6. Other serious medical illness or prior malignancies 7. Patients with BMD T-score ≤-2.5 8. Patients who were treated with bisphosphonate 9. Patients with postmenopausal state induced chemotherapy 10. Estimated life expectancy of <12 months

Additional Information

Official title Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment
Principal investigator Sehwan Han, MD.PhD.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Korean Breast Cancer Study Group.