NCT07480694尚未招募不适用
Real-world Study of Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With Antibody-drug Conjugates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
advanced HER2-negative breast cancer patients previously treated with ADC
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 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
次要结局
未报告次要终点
研究者
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