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

NCT00913016 | Unknown DMC

• 1 other identifier: KBCSG002
• Study Type: observational
• Target: 897
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.

  3 years

Study Arms (1)

letrozole (Femara)

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited into the study are postmenopausal women who had undergone surgery for primary breast cancer which was either estrogen receptor(ER) and/or progesteron receptor(PgR)-positive or of both.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Breast Cancer Study Group: lead

Study Sites (1)

Department of Surgery, Breast Cancer Center, Inje University Paik Hospital

Seoul, 139-707, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sehwan Han, MD.PhD.

  Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2009
• First Posted: June 3, 2009
• Study Start: June 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 17, 2010

Record last verified: 2009-12

Locations

KR (1)