Clinical trial · Observational
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
NCT00913016CI-TRIAL-00003157unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B questionnaire for 3 years from baseline.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- letrozole (Femara)
Primary outcomes (1)
- measure
- overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.