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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02615457
Eligibility Criteria:
Inclusion Criteria:
* Age: ≥ 18 and ≤ 75 years, female;
* Triple negative breast cancer has been surgically removed;
* The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
* Not receiving any preoperative anticancer drugs;
* The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
* Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \> 1.5×109/L;
* The expected survival time ≥ 6 months;
* The subjects volunteer to sign the informed consent.
Exclusion Criteria:
* Patients with stage IV breast cancer;
* Triple negative breast cancer was not surgically removed;
* Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
* Pregnant or lactating women;
* Those with active bleeding due to various reasons;
* Those with HIV infection or AIDS-associated diseases;
* Those with severe acute and chronic diseases;
* Those with severe diabetes;
* Those with serious infectious diseases;
* Those who can not take drugs by oral route;
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
* Conditions that are considered not suitable for this study investigators
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02615457
Study Brief:
Protocol Section:
NCT02615457