Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene (LEXTOP)

February 18, 2010 updated by: Korean Breast Cancer Study Group

Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene

The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene

  2. Secondary purpose

    • To evaluate follows after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene.

      1. Disease Free Survival rate(DFS)-12 months, 24 months
      2. Distant disease free survival rate(DDFS), Overall Survival(OS)
    • 12 months, 24 months, 36 months c. safety
    • Change of lipid profiles
    • Mortality and morbidity due to Cardiovascular disease
    • Incidence of Fracture
    • Change of Bone density
    • Common toxic effect

Study Type

Interventional

Enrollment (Anticipated)

495

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer.
  2. Removed the breast cancer histologically or cytologically
  3. No evidence of breast cancer in controlateral breast
  4. No evidence of metastasis
  5. Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months

  6. Postmenopausal state was defined the following conditions, at least one of a, b

    1. Serum FSH ≥ 30 mIU/mL
    2. Amenorrhea ≥ 1 year
  7. Estrogen receptor(+) or Progesterone receptor(+)
  8. No Evidence of Recurrence

Exclusion Criteria:

  1. Patient with hormone receptor negative
  2. Patients with malignancies
  3. Patients with other aromatase inhibitor and chemotherapy
  4. Patients with Other hormone therapy and Hormonal replacement therapy
  5. Patients with Hormone replacement therapy during taking Toremifene
  6. Estimated life expectancy of <12 months
  7. WBC<3,000/mm3 or Platelet count<100,000/mm3
  8. AST and/or ALT ≥2xUNL
  9. Alkaline phosphatase ≥2xUNL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrozole, DFS
Efficacy evaluation of extended letrozole after 5 year fareston use
Drug: Letrozole
Letrozole 2.5mg
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival rate
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease free survival rate
Time Frame: 12 months, 24 months
12 months, 24 months
Distant disease free survival rate
Time Frame: 12 months, 24 months, 36 months
12 months, 24 months, 36 months
Overall survival rate
Time Frame: 12, 24, 36 months
12, 24, 36 months
Toxicity was assessed by NCI-CTC version 3.0
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Breast Cancer Study Group

Investigators

  • Principal Investigator: Sei-Hyun Ahn, MD, Department of Surgery, Asan medical center, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

February 14, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2010

Last Update Submitted That Met QC Criteria

February 18, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCSG007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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