Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With ADC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Treatment Efficacy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Study of Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With Antibody-drug Conjugates
Overview
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.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: From enrollment to the last patient experiences disease progression or completes the 24-month follow-up.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07480694 · EVALUATE