Text Size

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

This study is currently recruiting participants.
Verified June 2011 by Novartis Korea Ltd.
Sponsor:
Information provided by:
Novartis Korea Ltd.
ClinicalTrials.gov Identifier:
NCT01249456
First received: November 25, 2010
Last updated: June 19, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition
Breast Cancer
Letrozole

Study Type: Observational
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

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Novartis Korea Ltd.:

Primary Outcome Measures:
  • To identify unknown adverse reactions, especially serious adverse reactions [ Time Frame: for 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 610
Study Start Date: May 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Femara(Letrozole)

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249456

Contacts
Contact: Minhee Che +82-2-768-9000 ext 274 minhee.che@novartis.com
Contact: Juyoung Lee +82-2-768-9000 ext 103 juyoung.lee@novartis.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Novartis Korea Ltd.
  More Information

No publications provided

Responsible Party: Minhee Che / Medical advisor, Novartis Korea Ltd.
ClinicalTrials.gov Identifier: NCT01249456     History of Changes
Other Study ID Numbers: CFEM345DKR04
Study First Received: November 25, 2010
Last Updated: June 19, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Letrozole
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013