NCT07480694
Not yet recruiting
Not Applicable
Real-world Study of Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With Antibody-drug Conjugates
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 400
- Primary Endpoint
- Progression-Free Survival (PFS)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
advanced HER2-negative breast cancer patients previously treated with ADC
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Jian Zhang,MD
Professor
Fudan University
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