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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05525767
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years old;
2. Signed the informed consent and volunteered to join the study with good compliance;
3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER/PR positive and HER2 negative) :
* HER2 negative was defined as 0/1+ on standard IHC test; HER2/CEP17 ratio was less than 2.0 or HER2 gene copy number was less than 4.
* ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%;
4\. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0);
5\. The main organs function well and meet the following standards:
A) Hemoglobin (HGB)≥90g/L;
B) Neutrophil absolute value (NEUT)≥1.5×109/L;
C) Platelet count (PLT)≥ 100×109/L;
D) leukocyte ≥3.0×109/L;
E) Total bilirubin \<1.5 ULN (upper limit of normal)
F) Creatinine \< 1.5×ULN
G) AST/ALT \< 1.5×ULN;
6\. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);
7\. The investigators determined that the patients were suitable for treatment with bevacizumab.
Exclusion Criteria:
1. Stage IV (metastatic) breast cancer;
2. Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.;
3. Patients who are participating in other intervention studies;
4. Women with confirmed pregnancy or lactation;
5. According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05525767
Study Brief:
Protocol Section:
NCT05525767