Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole Therapy

Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00913016

Enrollment

897

Registered

2009-06-03

Start date

2007-06-30

Completion date

2012-06-30

Last updated

2010-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

hormonal therapy(letrozole), postmenopausal breast cancer, quality of life

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results