Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01072318
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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01072318
Study Brief:
Protocol Section:
NCT01072318