NCT00913016UnknownNot Applicable
Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment
Korean Breast Cancer Study Group1 site in 1 country897 target enrollmentStarted: June 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 897
- Locations
- 1
- Primary Endpoint
- overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
Study Overview
Brief Summary
To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B questionnaire for 3 years from baseline.
Detailed Description
- TOI is the sum of the scores from the physical and functional well-being and the breast cancer subscales.
- To assess incidence of adverse events (including cardiovascular, cerebrovascular, and endocrine, musculoskeletal) in Korean postmenopausal breast cancer patients in early adjuvant setting.
- To assess the effect of letrozole (Femara) on BMD in early adjuvant setting.
- To assess the effect of letrozole (Femara) on total cholesterol in early adjuvant setting.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •serum FSH ≥ 30 mIU/mL
- •amenorrhea ≥ 1 year
- •oophorectomy
- •patients with estrogen receptor(+) and/or progesterone receptor(+)
- •WHO(ECOG) performance status 0-2
- •Adequate haematological function, renal function, hepatologic function.
- •No evidence of metastasis.
Exclusion Criteria
- •patient with hormone receptor negative.
- •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.
- •Other hormone therapy given within the previous 4 weeks.
- •Patients with other aromatase inhibitor and chemotherapy
- •Uncontrolled infection, medically uncontrollable heart disease
- •Other serious medical illness or prior malignancies
- •Patients with BMD T-score ≤-2.5
- •Patients who were treated with bisphosphonate
- •Patients with postmenopausal state induced chemotherapy
- •Estimated life expectancy of <12 months
Outcomes
Primary Outcomes
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
Time Frame: 3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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