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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Letrozole Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To identify unknown adverse reactions, especially serious adverse reactions

Time frame: for 3 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2015
Study completion: 2015
First posted: Nov 29, 2010
Registry last updated: Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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