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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT07255612
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years old , no limitation of gender;
2. locally advanced or metastatic triple-negative breast cancer;
3. have received at least two prior chemotherapy regimens(The recurrence of the last adjuvant chemotherapy is counted one line within 12 months after surgery);
4. At least one measurable lesion according to RECIST version 1.1;
5. The laboratory tests meet the following criteria:
Hemoglobin: ≥ 100 g / L (female), 110g / L (male) Neutrophil count : ≥2×10\^9/L Platelet count: ≥100×10\^9/L Creatinine：≤15mg / L or creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula); Total bilirubin：≤1.5× upper limit of normal (ULN) Alutamate aminotransferase (ALT) and glutamate aminotransferase (AST)≤ 3 ×ULN or 5 ×ULN (for patients with liver metastases) Albumin: ≥ 30 g / L;
6. Eastern Cooperative Oncology Group (ECOG) score \[0-1\] points;
7. The expected survival period is ≥3 months;
8. During the screening period, all female with potential fertility must have negative serum pregnancy tests and reliable contraception after signing the informed consent form until 3 months after the last dose;
9. Comprehend and voluntarily sign the informed consent form;
Exclusion Criteria:
1. Diagnosed other malignant disease besides breast cancerwithin 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection);
2. Main organ function not good enough;
3. Bone marrow invasion;
4. Require combined chemotherapy other than Eribulin;
5. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment;
6. QTcF \> 480 msec ( screening period) and QTcF\> 500 msec for patients with ventricular pacemaker implantation;
7. Previous hematopoietic stem cell or bone marrow transplantation;
8. Previous G-CSF treatment in the last 2 weeks;
9. Allergic to the study drug or the ingredients;
10. Any other situation where the researcher considers the patient not suitable to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07255612
Study Brief:
Protocol Section:
NCT07255612