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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Korean Breast Cancer Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00913016
First received: May 31, 2009
Last updated: February 14, 2010
Last verified: December 2009

May 31, 2009
February 14, 2010
June 2007
June 2012   (final data collection date for primary outcome measure)
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00913016 on ClinicalTrials.gov Archive Site
Not Provided
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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

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

  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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Breast Cancer
Not Provided
letrozole (Femara)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
897
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00913016
KBCSG002
Yes
Sehwan Han, Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Korean Breast Cancer Study Group
Not Provided
Principal Investigator: Sehwan Han, MD.PhD. Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
Korean Breast Cancer Study Group
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP