Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients
Study Details
Study Description
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 Toremifen treatment
Objectives:
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:
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To identify unknown adverse reactions, especially serious adverse reactions
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To evaluate incidence and descriptions of adverse reactions under the routine drug use
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To identify factors that may affect the safety of Femara®
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Femara(Letrozole)
|
Outcome Measures
Primary Outcome Measures
- To identify unknown adverse reactions, especially serious adverse reactions [for 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent form
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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
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Age ≥50 years with cessation of menses and Age <50 years Postmenopausal status defined by one of the following:
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FSH level > 30-40 IU/L
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cessation of menses over the past 1 year
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are/become amenorrheic due to either chemotherapy or LHRH, are/become amenorrheic due to surgical ovarian ablation
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The tumor was to be ER and/or PgR-positive or the receptor status could have been unknown
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No evidence of recurrence of the disease at entry
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Patient must be accessible for follow-up
Exclusion Criteria:
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Those patients known to have had receptor-negative primary tumors
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Any concurrent malignancy
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Patients who previously received hormone replacement therapy (HRT) during 5 years of adjuvant therapy with tamoxifen or toremifen
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Patients who are currently receiving other aromatase inhibitors, or chemotherapy
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Patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
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Life expectancy < 12 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CFEM345DKR04