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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01249456 |
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Date of registration:
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25/11/2010 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients
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Scientific title:
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An Observational, Multicenter Study on the Safety and Efficacy of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients Who Completed Adjuvant Tamoxifen or Toremifen Treatment |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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610 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01249456 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Retrospective
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Minhee Che |
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Address:
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Telephone:
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+82-2-768-9000 |
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Email:
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minhee.che@novartis.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent form
- Postmenopausal patients who had had a histologically or cytologically confirmed
breast cancer removed at the time of diagnosis with no evidence of metastases and who
had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before
entering the study
- Age =50 years with cessation of menses and Age <50 years Postmenopausal status
defined by one of the following:
- FSH level > 30-40 IU/L
- cessation of menses over the past 1 year
- are/become amenorrheic due to either chemotherapy or LHRH, are/become
amenorrheic due to surgical ovarian ablation
- The tumor was to be ER and/or PgR-positive or the receptor status could have been
unknown
- No evidence of recurrence of the disease at entry
- Patient must be accessible for follow-up
Exclusion Criteria:
- Those patients known to have had receptor-negative primary tumors
- Any concurrent malignancy
- Patients who previously received hormone replacement therapy (HRT) during 5 years of
adjuvant therapy with tamoxifen or toremifen
- Patients who are currently receiving other aromatase inhibitors, or chemotherapy
- Patients who have serious cardiovascular or hepatic disease with significantly
abnormal daily function and/or laboratory results
- Life expectancy < 12 months
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Letrozole
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Primary Outcome(s)
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To identify unknown adverse reactions, especially serious adverse reactions
[Time Frame: for 3 years]
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Secondary ID(s)
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CFEM345DKR04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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