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

NCT01249456 | Completed

• 1 other identifier: CFEM345DKR04
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

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:

1. 1.To identify unknown adverse reactions, especially serious adverse reactions
2. 2.To evaluate incidence and descriptions of adverse reactions under the routine drug use
3. 3.To identify factors that may affect the safety of Femara®
4. 4.To identify factors that may affect the efficacy of Femara®

Conditions

Breast Cancer; Letrozole

Outcome Measures

Primary Outcomes (1)

• To identify unknown adverse reactions, especially serious adverse reactions

  for 3 years

Study Arms (1)

Femara(Letrozole)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: November 29, 2010
• Study Start: May 1, 2006
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

KR (1)