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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07480694
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years old;
2. Inoperable locally advanced or metastatic breast cancer;
3. Planning to use a single-agent or combination treatment regimen based on eribulin;
4. HER2 negative (IHC 0,+, or ++ but ISH negative);
5. Previously received ADC treatment at the local advanced or metastatic disease stage;
6. Previously received chemotherapy (including ADC) for local advanced or metastatic disease no more than 2 lines, where one treatment line is defined as completing at least one cycle of chemotherapy;
7. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0-2;
8. The investigators have evaluated that the patient's organ and bone marrow functions are suitable for medication use and there are no relevant contraindications;
9. The subjects voluntarily join the study and sign the informed consent.
Exclusion Criteria:
1. HER2-positive tumors
2. The hormone receptor status is unknown;
3. Patients who have received eribulin treatment before;
4. Those who have had other malignant tumors within the past 5 years (excluding the following situations: cured skin basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma; second primary cancer that has been cured and has no recurrence within 5 years; subjects who have clearly identified the origin of the metastatic lesion as being from a certain primary tumor);
5. Mental illness or mental disorder, patients with poor compliance and inability to cooperate and describe treatment responses;
6. Pregnant or lactating women;
7. Other serious or uncontrollable diseases, or other conditions assessed by the researcher as not suitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07480694
Study Brief:
Protocol Section:
NCT07480694