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

Korean Breast Cancer Study Group

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT01072318

KBCSG007

Details and patient eligibility

About

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

Full 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

Enrollment: 495 estimated patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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495 participants in 1 patient group

Letrozole, DFS

Experimental group

Description:

Efficacy evaluation of extended letrozole after 5 year fareston use

Treatment:

Drug: Letrozole