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

Real-world Study of Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With Antibody-drug Conjugates

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07480694

Enrollment

400

Registered

2026-03-18

Start date

2026-03-01

Completion date

2028-02-01

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Efficacy

Keywords

Eribulin Mesylate-based Therapy, Advanced HER2-negative Breast Cancer, ADC

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression-Free Survival (PFS)	From enrollment to the last patient experiences disease progression or completes the 24-month follow-up.	the period from the start of eribulin mesylate-based therapy treatment until the disease progress or death from any cause, whichever occurred first

Contacts

CONTACTJian Zhang

syner2000@163.com64175590

PRINCIPAL_INVESTIGATORJian Zhang

Fudan University

Outcome results