Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients
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 Toremifen treatment
The major objective of the study is to assess safety and efficacy of Femara® in women who had undergone resection of a primary breast cancer and subsequently received prior adjuvant tamoxifen or toremifen therapy for 5 years in real-life condition.
The study aims at the following objectives:
- To identify unknown adverse reactions, especially serious adverse reactions
- To evaluate incidence and descriptions of adverse reactions under the routine drug use
- To identify factors that may affect the safety of Femara®
- To identify factors that may affect the efficacy of Femara®
Methodology: This will be an open-label, multi-center, single-arm, observational phase IV study.
Number of centers & patients: Approximately 610 (planned No. of patients for total study period) patients from 4 centers will be enrolled in this study.
Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling.
Investigational drug: Femara® will be administered orally as described in "dose & administration" of local product labeling up to 3 years.
Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3 years with renewal of contract on yearly basis.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||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|
- To identify unknown adverse reactions, especially serious adverse reactions [ Time Frame: for 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249456
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|