Status:
UNKNOWN
Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole Therapy
Lead Sponsor:
Korean Breast Cancer Study Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
45+ years
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
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 en...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
897 Patients enrolled
Trial Details
Trial ID
NCT00913016
Start Date
June 1 2007
End Date
June 1 2012
Last Update
February 17 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Seoul, South Korea, 139-707