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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR+/HER2- advanced breast cancer | Efficacy and Safety of Eribulin in the Treatment of HR+/HER2- Advanced Breast Cancer |
| |
| HER2+ advanced breast cancer | Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer |
| |
| triple negative advanced breast cancer | Efficacy and Safety of Eribulin and Immunotherapy in the Treatment of triple negative advanced breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug | Eribulin,1.4mg/m2,Intravenous infusion,d1,d8,3-week cycle |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Partial remission, PR | the diameter of target lesions diminished more than 30% and lasted for 4 weeks | up to 12 month |
| Disease stable, SD | the sum of the maximum diameter of the target lesion is smaller than PR, or the increase is not up to PD |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianli Dr. Zhao, doctor | Contact | 86-20-34070870 | zhaojli5@mail.sysu.edu.cn | |
| Ying Dr. Wang, doctor | Contact | 86-20-34070499 | wangy556@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat Sen Memorial Hospital,Sun Yat sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31087564 | Background | Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20. | |
| 29594360 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C490954 | eribulin |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| C000622954 | pyrotinib |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Trastuzumab | Drug | Trastuzumab,8mg/kg for the first dose,6mg/kg for the following dose,Intravenous infusion,3-week cycle |
|
|
| pertuzumab | Drug | Pertuzumab,,840mg for the first dose,420mg for the following dose,Intravenous infusion,3-week cycle |
|
|
| Pyrotinib | Drug | Pyrotinib,400mg,oral,every day |
|
| Pembrolizumab | Drug | Pembrolizumab,200mg,Intravenous infusion,3-week cycle |
|
|
| Camerlizumab | Drug | Camerlizumab,200mg,Intravenous infusion,3-week cycle |
|
| 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 |
| up to 12 month |
| Disease progression, PD | he sum of the maximum diameter of the target lesion increased by at least 20%, and its absolute value increased by at least 5 mm, New lesions are also considered as PD | up to 12 month |
| Objective response rate , ORR | according to recist1.1 criteria, the proportion of patients whose best remission is CR or PR in the total number of evaluable patients. | up to 12 month |
| Clinical benefit rate, CBR | according to recist1.1 criteria, the proportion of patients with Cr or PR or SD ≥ 24 weeks in the total number of evaluable patients. | up to 12 month |
| Exploration of biomarkers | Objective to explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on. | the first week after the enrollment |
| the rate of adverse events | The probability and severity of adverse reactions were analyzed up to 2 year after enrollment | up to 24 month |
| Result |
| Kimura K, Iwamoto M, Tanaka S, Yamamoto D, Yoshidome K, Ogura H, Terasawa R, Matsunami N, Takahashi Y, Nitta T, Morimoto T, Fujioka H, Kawaguchi K, Uchiyama K. A phase II, multicenter, single-arm trial of eribulin as first- or second-line chemotherapy for HER2-negative advanced or metastatic breast cancer: evaluation of efficacy, safety, and patient-reported outcomes. Cancer Chemother Pharmacol. 2018 May;81(5):923-933. doi: 10.1007/s00280-018-3567-y. Epub 2018 Mar 28. |
| 29716585 | Result | Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander GC, Omar A, Ford DE; National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee. Clinical trial registration and reporting: a survey of academic organizations in the United States. BMC Med. 2018 May 2;16(1):60. doi: 10.1186/s12916-018-1042-6. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |