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Status unknownNCT00913016Updated Feb 17, 2010

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

An observational study in Breast Cancer, sponsored by Korean Breast Cancer Study Group. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2010-02-17.

Sponsored by Korean Breast Cancer Study Group · Observational

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
897
Ages
45 Years and older
Sex
Female
01

Study summary

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

Read the 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.
02

Conditions studied

  • Breast Cancer

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Keywords

  • hormonal therapy(letrozole)
  • postmenopausal breast cancer
  • quality of life
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 897 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Korean Breast Cancer Study Group is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
897 participants (estimated)

Groups and cohorts

  • letrozole (Femara)
06

What researchers measure

Primary outcomes

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

    Time frame: 3 years

07

Study locations

1 site
  • Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
    Seoul, 139-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00913016
Lead sponsor
Korean Breast Cancer Study Group
First posted
Jun 3, 2009
Start date
Jun 2007
Primary completion
Jun 2012 (estimated)
Completion
Jun 2012 (estimated)
Last update
Feb 17, 2010

Study contacts

Sehwan Han, MD.PhD.
principal investigator · Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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