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 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT06881550
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet all of the following enrollment criteria to be enrolled in this trial:
1. be 18-75 years of age (both 18 and 75);
2. female;
3. all patients have histologically confirmed breast cancer;
4. expected to receive surgical treatment;
5. expected survival of ≥ 1 year;
6. the level of function of vital organs must meet the following requirements:
1. Bone marrow function Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; Platelets ≥ 100 x 10\^9/L; Hemoglobin ≥ 90 g/L;
2. Liver and kidney function Albumin level ≥ 3.0 g/dL; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 x ULN; Urea nitrogen and serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula);
3. Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
4. Echocardiogram (ECHO) showing cardiac left ventricular ejection fraction (LVEF) ≥ 50%;
8\. voluntarily accept the treatment and sign the informed consent form, have understood the purpose of this study and the experimental steps, good compliance, and comply with the relevant requirements of this trial protocol.
Exclusion Criteria:
1. intolerance to or poor compliance with herbal medicines;
2. inability to swallow, chronic diarrhea and intestinal obstruction, and the presence of multiple factors affecting the administration and absorption of medications;
3. severe cardiac, hepatic, renal and other vital organ insufficiency;
4. combination of serious complications, active infection, persistent fever, serious bleeding tendency, hematopoietic function abnormality;
5. a known history of allergy to the drug components of this regimen;
6. have a history of immunodeficiency, including testing positive for HIV, HCV, active viral hepatitis B, or suffering from other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation
7. a history of any cardiac disease, including (1) arrhythmia requiring medication or of clinical significance, (2) myocardial infarction, (3) heart failure, (4) any other cardiac disease judged by the investigator to be inappropriate for participation in the study, etc;
8. pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test or female patients of childbearing potential who are unwilling to use effective contraception throughout the trial period;
9. in the judgment of the investigator, have a serious concomitant medical condition that jeopardizes the patient's safety, or interferes with the patient's ability to complete the study (including, but not limited to, severe hypertension that cannot be controlled by medication, severe diabetes mellitus, active infection, etc.)
10. is unconscious, non-verbal or non-reading, unable to communicate normally, and unable to cooperate in completing the questionnaire assessment;
11. a previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia
12. suspected or confirmed history of alcohol or drug abuse;
13. any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06881550
Study Brief:
Protocol Section:
NCT06881550