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

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ClinicalTrials.gov Identifier: NCT01249456
Recruitment Status : Completed
First Posted : November 29, 2010
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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. 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 or disease
Breast Cancer Letrozole

Study Type : Observational
Actual Enrollment : 392 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Group/Cohort
Femara(Letrozole)



Primary Outcome Measures :
  1. To identify unknown adverse reactions, especially serious adverse reactions [ Time Frame: for 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249456


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01249456     History of Changes
Other Study ID Numbers: CFEM345DKR04
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs