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

NCT07480694 | Not Yet Recruiting

• 1 other identifier: EVALUATE
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Treatment Efficacy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  the period from the start of eribulin mesylate-based therapy treatment until the disease progress or death from any cause, whichever occurred first

  From enrollment to the last patient experiences disease progression or completes the 24-month follow-up.

Study Arms (1)

advanced HER2-negative breast cancer patients previously treated with ADC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced HER2-negative breast cancer patients previously treated with ADC

You may qualify if:

• At least 18 years old;
• Inoperable locally advanced or metastatic breast cancer;
• Planning to use a single-agent or combination treatment regimen based on eribulin;
• HER2 negative (IHC 0,+, or ++ but ISH negative);
• Previously received ADC treatment at the local advanced or metastatic disease stage;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0-2;
• The investigators have evaluated that the patient's organ and bone marrow functions are suitable for medication use and there are no relevant contraindications;
• The subjects voluntarily join the study and sign the informed consent.

You may not qualify if:

• HER2-positive tumors
• The hormone receptor status is unknown;
• Patients who have received eribulin treatment before;
• 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);
• Mental illness or mental disorder, patients with poor compliance and inability to cooperate and describe treatment responses;
• Pregnant or lactating women;
• Other serious or uncontrollable diseases, or other conditions assessed by the researcher as not suitable for enrollment.

Sponsors & Collaborators

• Fudan University: lead

Study Officials

• Jian Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhang

CONTACT

64175590; syner2000@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03