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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Korean Breast Cancer Study Group.
Recruitment status was:  Enrolling by invitation
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: 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 ]

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

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Letrozole
Toremifene
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
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 26, 2017