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

NCT04683445 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-12-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04683445 on ClinicalTrials.gov