A Real-world Study: Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression Free Survival，PFS
研究概览
简要总结
Chemotherapy is an important means to prolong the survival time of advanced breast cancer. As a new type of microtubule inhibitor, eribulin has a unique mechanism of action. Compared with single drug chemotherapy, it can improve the overall survival time of 2.5 months, increase the clinical benefit rate by 5 times, and the tolerance of eribulin is good. Therefore, the guidelines at home and abroad recommend eribulin for the rescue of advanced breast cancer.
However, up to now, there is no large sample data on the efficacy of eribulin combined with anti HER2 targeted therapy in HER2 + metastatic breast cancer, and the efficacy of combined immunotherapy in triple negative metastatic breast cancer. Moreover, as a newly marketed chemotherapy drug in China, the efficacy and safety data of eribulin in Chinese population are relatively lacking. Therefore, we plan to include different types and line numbers of advanced breast cancer patients based on the Chinese population through real-world research, and receive the treatment regimen containing eribulin respectively. In HR + / her2-mbc, we use eribulin monotherapy; in HER2 + MBC, we use eribulin + anti HER2 targeted therapy; in TNBC, we use eribulin + immunotherapy / chemotherapy, The efficacy and safety of eribulin were evaluated.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients (aged 18-80 years, including 18 and 80 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;
- •The starting time of eribulin treatment was between January 2021 and December 2021;
- •They received no more than 2-line chemotherapy in the past;
- •In HR + / her2-mbc, patients were treated with eribulin monotherapy; in HER2 + MBC, patients were treated with eribulin + anti HER2 targeted therapy; in TNBC, patients were treated with eribulin + immunotherapy / chemotherapy; in patients with HER2 + MBC, patients were treated with eribulin + immunotherapy /chemotherapy;
排除标准
- •Patients without pathological diagnosis;
- •Patients with central nervous system metastasis;
- •She has received more than two chemotherapy regimens for metastatic breast cancer;
- •Participating in any intervention drug clinical trials.
- •Those who have been known to have allergic history to the components of this regimen;
- •The patient, the patient, or the person with serious harm to the safety of the study.
- •Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)
研究组 & 干预措施
HR+/HER2- advanced breast cancer
Efficacy and Safety of Eribulin in the Treatment of HR+/HER2- Advanced Breast Cancer
干预措施: Eribulin (Drug)
HER2+ advanced breast cancer
Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer
干预措施: Eribulin (Drug)
HER2+ advanced breast cancer
Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer
干预措施: Trastuzumab (Drug)
HER2+ advanced breast cancer
Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer
干预措施: pertuzumab (Drug)
HER2+ advanced breast cancer
Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer
干预措施: Pyrotinib (Drug)
triple negative advanced breast cancer
Efficacy and Safety of Eribulin and Immunotherapy in the Treatment of triple negative advanced breast cancer
干预措施: Eribulin (Drug)
triple negative advanced breast cancer
Efficacy and Safety of Eribulin and Immunotherapy in the Treatment of triple negative advanced breast cancer
干预措施: Pembrolizumab (Drug)
triple negative advanced breast cancer
Efficacy and Safety of Eribulin and Immunotherapy in the Treatment of triple negative advanced breast cancer
干预措施: Camerlizumab (Drug)
结局指标
主要结局
Progression Free Survival，PFS
时间窗: up to 24 month
The time from the beginning of treatment to the progression or death of the patient
次要结局
- overall survival，OS(up to 36 month)
- Quality of life scale score，QoL(up to 24 month)
- Complete remission, CR(up to 12 month)
研究者
Ying Wang
associate chief physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University