Breast CancerNCT00913016
Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole Therapy
An observational study of Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
Trial summary
To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B questionnaire for 3 years from baseline. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 897 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2007to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- serum FSH ≥ 30 mIU/mL
- amenorrhea ≥ 1 year
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Seoul, 139-707
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- hormonal therapy(letrozole), postmenopausal breast cancer, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| letrozole (Femara) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2007
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 897 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Breast Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Sehwan Han, MD.PhD., Principal investigator, Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913016
- Sponsor's protocol ID
- KBCSG002
- Status last verified
- Dec 2009
- First submitted
- 31 May 2009
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment
- ClinicalTrials.gov ID
- NCT00913016
- Acronym / sponsor ID
- KBCSG002
- Conditions
- Breast Cancer
- Keywords
- hormonal therapy(letrozole), postmenopausal breast cancer, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 897 participants (estimated)
- Lead sponsor
- Korean Breast Cancer Study GroupUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| letrozole (Femara) | – | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sehwan Han, MD.PhD. principal investigator
Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2010.