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:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT02506361
Eligibility Criteria:
Inclusion Criteria:
For inclusion in the study, subjects must fulfil all of the following criteria:
1. . Signed and dated informed consent indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
2. . Invasive breast cancer confirmed by histology or cytology with the tumor complete resection.
3. . Patients without remote organs metastasis.
4. . The Ages of patients ≥ 18 years and ≤70 years.
5. . Patients with positive axillary lymph nodes, or negative axillary lymph nodes plus one of these conditions: Triple-negative breast cancer, HER- 2(+),Ki-67≥15%.
6. . The values of aspartate aminotransferase(AST),alanine aminotransferase(ALT), alkaline phosphatase(ALP), total bilirubin(TBIL), UREA, CREA were less than 2 times of upper limits of normal at the beginning of aromatase inhibitors（AIs） therapy.
7. . TOP2α is available to be detected in the primary tumour tissue.
8. . Patients received the regimens of anthracyclines followed Taxanes or containing no Taxanes non-dose dense chemotherapy suggested by the guidelines of National Comprehensive Cancer Network （NCCN) 2014.
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
1. . Patients is in the period of pregnancy or lactation.
2. . Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ.
3. . Previous received neo-adjuvant therapy, including chemotherapy, radiotherapy or endocrinotherapy.
4. . Presence of other life-threatening cancers.
5. . Any severe concomitant condition: uncontrolled cardiac disease or uncontrolled diabetes mellitus. et al.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02506361
Study Brief:
Protocol Section:
NCT02506361