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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT04067102
Eligibility Criteria:
Inclusion Criteria:
* Female, aged ≥ 18 yrs and ≤70 yrs；
* Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy；
* The expression of ER\<10%，PR \<10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene；
* ECOG performance status 0-1；
* LVEF≥55%；
* Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L；
* Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN；
* The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.
Exclusion Criteria:
* Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason；
* New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)；
* Patients with severe systemic infections or other serious illnesses；
* Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients；
* Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated；
* Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial；
* Participated in other experimental studies within 30 days before the first dose of study drug administration
* Researchers judged patients who were unsuitable for this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04067102
Study Brief:
Protocol Section:
NCT04067102