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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01072318
• Other study ID #: KBCSG007
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 14, 2010
• Last updated: February 18, 2010
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: February 2010
• Source: Korean Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 495
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole
Letrozole 2.5mg

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival rate		3 years	Yes
Secondary	Disease free survival rate		12 months, 24 months	Yes
Secondary	Distant disease free survival rate		12 months, 24 months, 36 months	Yes
Secondary	Overall survival rate		12, 24, 36 months	Yes
Secondary	Toxicity was assessed by NCI-CTC version 3.0		36 months	Yes