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

Phase 4

• Conditions: Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT01072318
• Lead Sponsor: Korean Breast Cancer Study Group

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

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-02
• Study First Submitted: 2010-02-14
• Study First Submitted QC: 2010-02-18
• Last Update Submitted: 2010-02-18
• Study First Posted: 2010-02-22
• Last Update Posted: 2010-02-22
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 495

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole, DFS	Letrozole	Efficacy evaluation of extended letrozole after 5 year fareston use

Primary Outcome Measures

Name	Time	Method
Disease free survival rate	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Surgery, Asan medical center; 🇰🇷 Seoul, Korea, Republic of