Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Real-world Study: Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Eribulin
* Drug: Trastuzumab
* Drug: pertuzumab
* Drug: Pyrotinib
* Drug: Pembrolizumab
* Drug: Camerlizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HR+/HER2- advanced breast cancer<br>Efficacy and Safety of Eribulin in the Treatment of HR+/HER2- Advanced Breast Cancer | Drug: Eribulin<br>* Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle<br>* Other names: Halaven;|
| HER2+ advanced breast cancer<br>Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer | Drug: Eribulin<br>* Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle<br>* Other names: Halaven;Drug: Trastuzumab<br>* Trastuzumab，8mg/kg for the first dose，6mg/kg for the following dose，Intravenous infusion，3-week cycle<br>* Other names: Herceptin;Drug: pertuzumab<br>* Pertuzumab，，840mg for the first dose，420mg for the following dose，Intravenous infusion，3-week cycle<br>* Other names: Perjeta;Drug: Pyrotinib<br>* Pyrotinib，400mg，oral，every day<br>|
| triple negative advanced breast cancer<br>Efficacy and Safety of Eribulin and Immunotherapy in the Treatment of triple negative advanced breast cancer | Drug: Eribulin<br>* Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle<br>* Other names: Halaven;Drug: Pembrolizumab<br>* Pembrolizumab，200mg，Intravenous infusion，3-week cycle<br>* Other names: Keytruda;Drug: Camerlizumab<br>* Camerlizumab，200mg，Intravenous infusion，3-week cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival，PFS | The time from the beginning of treatment to the progression or death of the patient | up to 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival，OS | The time from the beginning of treatment to the death of the patient | up to 36 month | 
| Quality of life scale score，QoL | The quality of life score of patients during treatment was analyzed（FACT-B）. Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale) Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale) | up to 24 month | 
| Complete remission, CR | all target lesions disappeared, no new lesions appeared, and tumor markers were normal, which lasted for at least 4 weeks | up to 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, eribulin, real-world study