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NCT Number: NCT07480694

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhang

CONTACT

[email protected]

64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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