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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Letrozole
Sponsored by
Korean Breast Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, extended adjuvant hormonal therapy, letrozole, Toremifene

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, Asan medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Letrozole, DFS

Arm Description

Efficacy evaluation of extended letrozole after 5 year fareston use

Outcomes

Primary Outcome Measures

Disease free survival rate

Secondary Outcome Measures

Disease free survival rate
Distant disease free survival rate
Overall survival rate
Toxicity was assessed by NCI-CTC version 3.0

Full Information

First Posted
February 14, 2010
Last Updated
February 18, 2010
Sponsor
Korean Breast Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01072318
Brief Title
Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
Acronym
LEXTOP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Korean Breast Cancer Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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 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. Disease Free Survival rate(DFS)-12 months, 24 months 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, extended adjuvant hormonal therapy, letrozole, Toremifene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
495 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Letrozole, DFS
Arm Type
Experimental
Arm Description
Efficacy evaluation of extended letrozole after 5 year fareston use
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Letrozole 2.5mg
Primary Outcome Measure Information:
Title
Disease free survival rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Disease free survival rate
Time Frame
12 months, 24 months
Title
Distant disease free survival rate
Time Frame
12 months, 24 months, 36 months
Title
Overall survival rate
Time Frame
12, 24, 36 months
Title
Toxicity was assessed by NCI-CTC version 3.0
Time Frame
36 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer. Removed the breast cancer histologically or cytologically No evidence of breast cancer in controlateral breast No evidence of metastasis Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months Postmenopausal state was defined the following conditions, at least one of a, b Serum FSH ≥ 30 mIU/mL Amenorrhea ≥ 1 year Estrogen receptor(+) or Progesterone receptor(+) No Evidence of Recurrence Exclusion Criteria: Patient with hormone receptor negative Patients with malignancies Patients with other aromatase inhibitor and chemotherapy Patients with Other hormone therapy and Hormonal replacement therapy Patients with Hormone replacement therapy during taking Toremifene Estimated life expectancy of <12 months WBC<3,000/mm3 or Platelet count<100,000/mm3 AST and/or ALT ≥2xUNL Alkaline phosphatase ≥2xUNL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sei-Hyun Ahn, MD
Organizational Affiliation
Department of Surgery, Asan medical center, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Asan medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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