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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT06857305
Eligibility Criteria:
Inclusion Criteria:
1. Over 18 years old
2. ECOG 0-2
3. Expected survival of not less than 12 weeks
4. At least one measurable lesion
5. With HER2 negative locally recurrent or metastatic breast cancer
6. Metastatic breast cancer advanced stage received ≤3 lines of chemotherapy
7. Previous anthracycline and paclitaxel therapy
8. Well organ functional status 1）routine blood test
* ANC≥1.5×109/L；
* PLT≥90×109/L；
* Hb≥90 g/L； 2）blood biochemistry
* TBIL≤1.5×ULN；
* ALT/AST≤2×ULN；patients with liver matastasis ALT/AST≤5×ULN；
* BUN/Cr≤1.5×ULN and creatinine clearance ≥50 mL/min （Cockcroft-Gault） 3）cardiology ultrasound
* LVEF≥50%；
9. Signed informed consent, good compliance and willingness to cooperate with follow-up visits
Exclusion Criteria:
1. With third interstitial fluid that cannot be controlled by drainage or other means
2. Symptomatic brain or meningeal metastases
3. Patients with only bone or skin as the sole target lesion
4. Pre-existing other malignant tumors
5. Patients who have used eribulin in the adjuvant and palliative phases of care
6. Known history of allergy to components of this regimen; history of immunodeficiency
7. Pregnant or breastfeeding 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
8. Have a concomitant illness that, in the investigator's judgment, seriously jeopardizes the patient's safety, or interferes with the patient's ability to complete the study.
9. A clear past history of neurological or psychiatric disorders
10. Any other condition for which the investigator believes the patient is not suitable to participate in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06857305
Study Brief:
Protocol Section:
NCT06857305