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

Tracking Information

First Received Date ^ICMJE

May 31, 2009

Last Updated Date

February 14, 2010

Start Date ^ICMJE

June 2007

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00913016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

TOI is the sum of the scores from the physical and functional well-being and the breast cancer subscales.
To assess incidence of adverse events (including cardiovascular, cerebrovascular, and endocrine, musculoskeletal) in Korean postmenopausal breast cancer patients in early adjuvant setting.
To assess the effect of letrozole (Femara) on BMD in early adjuvant setting.
To assess the effect of letrozole (Femara) on total cholesterol in early adjuvant setting.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

letrozole (Femara)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

897

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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
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.

Exclusion Criteria:

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

Gender

Female

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00913016

Other Study ID Numbers ^ICMJE

KBCSG002

Has Data Monitoring Committee

Yes

Responsible Party

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

Study Sponsor ^ICMJE

Korean Breast Cancer Study Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sehwan Han, MD.PhD.

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

Information Provided By

Korean Breast Cancer Study Group

Verification Date

December 2009

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

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