Know Cancer

or
forgot password

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


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Cancer, Letrozole

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

To identify unknown adverse reactions, especially serious adverse reactions

Outcome Time Frame:

for 3 years

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

CFEM345DKR04

NCT ID:

NCT01249456

Start Date:

May 2006

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Letrozole
  • Breast Neoplasms

Name

Location