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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01072318
First received: February 14, 2010
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Letrozole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • Disease free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease free survival rate [ Time Frame: 12 months, 24 months ] [ Designated as safety issue: Yes ]
  • Distant disease free survival rate [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]
  • Overall survival rate [ Time Frame: 12, 24, 36 months ] [ Designated as safety issue: Yes ]
  • Toxicity was assessed by NCI-CTC version 3.0 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 495
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole, DFS
Efficacy evaluation of extended letrozole after 5 year fareston use
Drug: Letrozole
Letrozole 2.5mg
Other Name: Femara

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
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072318

Locations
Korea, Republic of
Department of Surgery, Asan medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Breast Cancer Study Group
Investigators
Principal Investigator: Sei-Hyun Ahn, MD Department of Surgery, Asan medical center, South Korea
  More Information

No publications provided

Responsible Party: Sei-Hyun Ahn, Asan medical center
ClinicalTrials.gov Identifier: NCT01072318     History of Changes
Other Study ID Numbers: KBCSG007
Study First Received: February 14, 2010
Last Updated: February 18, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Breast Cancer Study Group:
Breast cancer
extended adjuvant hormonal therapy
letrozole
Toremifene

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Toremifene
Letrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014