Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer
NCT ID: NCT04683445
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2020-12-01
2023-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HR+/HER2- advanced breast cancer
Efficacy and Safety of Eribulin in the Treatment of HR+/HER2- Advanced Breast Cancer
Eribulin
Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle
HER2+ advanced breast cancer
Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer
Eribulin
Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle
Trastuzumab
Trastuzumab，8mg/kg for the first dose，6mg/kg for the following dose，Intravenous infusion，3-week cycle
pertuzumab
Pertuzumab，，840mg for the first dose，420mg for the following dose，Intravenous infusion，3-week cycle
Pyrotinib
Pyrotinib，400mg，oral，every day
triple negative advanced breast cancer
Efficacy and Safety of Eribulin and Immunotherapy in the Treatment of triple negative advanced breast cancer
Eribulin
Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle
Pembrolizumab
Pembrolizumab，200mg，Intravenous infusion，3-week cycle
Camerlizumab
Camerlizumab，200mg，Intravenous infusion，3-week cycle
Interventions
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Eribulin
Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle
Trastuzumab
Trastuzumab，8mg/kg for the first dose，6mg/kg for the following dose，Intravenous infusion，3-week cycle
pertuzumab
Pertuzumab，，840mg for the first dose，420mg for the following dose，Intravenous infusion，3-week cycle
Pyrotinib
Pyrotinib，400mg，oral，every day
Pembrolizumab
Pembrolizumab，200mg，Intravenous infusion，3-week cycle
Camerlizumab
Camerlizumab，200mg，Intravenous infusion，3-week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The starting time of eribulin treatment was between January 2021 and December 2021;
3. They received no more than 2-line chemotherapy in the past;
4. 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
2. Patients with central nervous system metastasis;
3. She has received more than two chemotherapy regimens for metastatic breast cancer;
4. Participating in any intervention drug clinical trials.
5. Those who have been known to have allergic history to the components of this regimen;
6. The patient, the patient, or the person with serious harm to the safety of the study.
7. 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)
18 Years
80 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Ying Wang
associate chief physician
Locations
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Sun Yat Sen Memorial Hospital，Sun Yat sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ying Wang
Role: primary
Jianli Zhao
Role: backup
References
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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.
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.
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.
Other Identifiers
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2020-KY-064
Identifier Type: -
Identifier Source: org_study_id