Status:
COMPLETED
Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Letrozole
Eligibility:
FEMALE
Brief Summary
Title of study: 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 To...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT01249456
Start Date
May 1 2006
End Date
April 1 2015
Last Update
June 25 2015
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea