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


Phase 4
45 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Sehwan Han, MD.PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Korea: Food and Drug Administration

Study ID:

KBCSG002

NCT ID:

NCT00913016

Start Date:

June 2007

Completion Date:

June 2012

Related Keywords:

  • Breast Cancer
  • hormonal therapy(letrozole)
  • postmenopausal breast cancer
  • quality of life
  • Breast Neoplasms

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