Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With ADC

Fudan University

Status: Not yet enrolling

Conditions: Treatment Efficacy

Study type: Observational

Funder types: Other

Identifiers

NCT07480694

EVALUATE

Details and patient eligibility

About

This study is a real-world study. we collected patients with advanced HER2-negative breast cancer previously treated with antibody-drug conjugates, and received eribulin mesylate-based therapy post-ADC. We retrospectively collect the data on previous systemic treatment, and prospectively collect the treatment data of the therapeutic regimens based on eribulin mesylate.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

advanced HER2-negative breast cancer patients previously treated with ADC