NCT04683445

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin	Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle
DRUG	Trastuzumab	Trastuzumab，8mg/kg for the first dose，6mg/kg for the following dose，Intravenous infusion，3-week cycle
DRUG	pertuzumab	Pertuzumab，，840mg for the first dose，420mg for the following dose，Intravenous infusion，3-week cycle
DRUG	Pyrotinib	Pyrotinib，400mg，oral，every day
DRUG	Pembrolizumab	Pembrolizumab，200mg，Intravenous infusion，3-week cycle
DRUG	Camerlizumab	Camerlizumab，200mg，Intravenous infusion，3-week cycle

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-12-24
• Last updated: 2020-12-24

Locations

1 site across 1 country: China