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

• Sponsor: Korean Breast Cancer Study Group (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00913016
• Collaborator: (none)
• Enrollment: 897
• Location: 1
• Duration (Months): 60
• Patients Per Site Per Month: 14.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 897 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment
• Study Start Date: Jun 1, 2007
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
letrozole (Femara)

Outcome Measures

Primary Outcome Measures

1. overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire. [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

2. serum FSH ≥ 30 mIU/mL

3. amenorrhea ≥ 1 year

4. oophorectomy

5. patients with estrogen receptor(+) and/or progesterone receptor(+)

6. WHO(ECOG) performance status 0-2

7. Adequate haematological function, renal function, hepatologic function.

8. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Breast Cancer Center, Inje University Paik Hospital	Seoul		Korea, Republic of	139-707

Sponsors and Collaborators

• Korean Breast Cancer Study Group

Investigators

• Principal Investigator: Sehwan Han, MD.PhD., Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00913016
• Other Study ID Numbers: KBCSG002
• First Posted: Jun 3, 2009
• Last Update Posted: Feb 17, 2010
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: hormonal therapy(letrozole); postmenopausal breast cancer; quality of life
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 17, 2010