Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249456
• Other study ID #: CFEM345DKR04
• Status: Completed
• Phase: N/A
• First received: November 25, 2010
• Last updated: June 24, 2015
• Start date: May 2006
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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:

1. To identify unknown adverse reactions, especially serious adverse reactions

2. To evaluate incidence and descriptions of adverse reactions under the routine drug use

3. To identify factors that may affect the safety of Femara®

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Letrozole

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify unknown adverse reactions, especially serious adverse reactions		for 3 years	Yes