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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072318

Acronym

LEXTOP

Enrollment

495

Registered

2010-02-22

Start date

2010-01-31

Completion date

2014-01-31

Last updated

2010-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, extended adjuvant hormonal therapy, letrozole, Toremifene

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

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

Interventions

DRUGLetrozole

Letrozole 2.5mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
Disease free survival rate	3 years

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026