Clinical trial NCT01072318: Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast cancer
extended adjuvant hormonal therapy
letrozole
Toremifene
Lead sponsor: Korean Breast Cancer Study Group
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 495
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Disease free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Disease free survival rate
timeFrame: 12 months, 24 months
measure: Distant disease free survival rate
timeFrame: 12 months, 24 months, 36 months
measure: Overall survival rate
timeFrame: 12, 24, 36 months
measure: Toxicity was assessed by NCI-CTC version 3.0
timeFrame: 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Asan medical center
Study officials:
affiliation: Department of Surgery, Asan medical center, South Korea
name: Sei-Hyun Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: