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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00913016
• Other study ID #: KBCSG002
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 31, 2009
• Last updated: February 14, 2010
• Start date: June 2007
• Est. completion date: June 2012

Study information

• Verified date: December 2009
• Source: Korean Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 897
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Breast Cancer Center, Inje University Paik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.		3 years	Yes