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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT05251766
Eligibility Criteria:
Inclusion Criteria:
1. Female patients with age range ≥ 18 years;
2. a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
3. HER2 negative breast cancer, tumor \>2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests).
4. Known hormone receptor status (estrogen receptor \[ER\], progesterone receptor \[PR\]), known Ki67 value;
5. Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
6. patients have not previously had breast cancer treatment.
7. During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
8. Subjects have the ability to understand, agree and sign the study informed consent form (ICF) before initiating any protocol related procedures; The subject has the ability to express consent (when applicable);
9. Normal blood, kidney and liver functions (ANC ≥ 1500 / mm3, platelet（PLT）≥ 100000 / mm3, serum creatinine and total bilirubin ≤ 1.5 times of the upper limit of normal, glutamic oxalacetic transaminase(AST) and glutamic-pyruvic transaminase（ALT） ≤ 3 times of the upper limit of normal).
Exclusion Criteria:
1. bilateral invasive breast cancer, metastatic disease or other malignant tumors.
2. Surgical axillary staging surgery was performed within 6 months before entering the study;
3. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
4. before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
5. Patients with central nervous system metastasis or \> grade 1 peripheral neuropathy;
6. Patients with severe myelosuppression at the time of screening;
7. Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening;
8. Other concomitant diseases that the researchers believe are seriously harmful to the safety of patients or will hinder the implementation or completion of treatment plan (such as untreated congenital heart disease, glomerulonephritis, etc.);
9. Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel;
10. Patients with mental disorders;
11. Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half lives of the study drug) from the end of the previous clinical study (last administration);
12. Other situations that may affect the progress of clinical research and the judgment of research results and are not suitable for inclusion in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05251766
Study Brief:
Protocol Section:
NCT05251766