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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
History of Changes
  Purpose

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


Condition Phase
Breast Cancer
 Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 897
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
letrozole (Femara)

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.
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913016

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Sehwan Han, Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
ClinicalTrials.gov Identifier: NCT00913016     History of Changes
Other Study ID Numbers: KBCSG002
Study First Received: May 31, 2009
Last Updated: February 14, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Breast Cancer Study Group:
hormonal therapy(letrozole)
postmenopausal breast cancer
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013