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

NCT04683445 | Unknown

• 1 other identifier: 2020-KY-064
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast Cancer; eribulin; real-world study

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival，PFS

  The time from the beginning of treatment to the progression or death of the patient

  up to 24 month

Secondary Outcomes (3)

• overall survival，OS

  up to 36 month

• Quality of life scale score，QoL

  up to 24 month

• Complete remission, CR

  up to 12 month

Other Outcomes (7)

• Partial remission, PR

  up to 12 month

• Disease stable, SD

  up to 12 month

• Disease progression, PD

  up to 12 month

Study Arms (3)

HR+/HER2- advanced breast cancer

Efficacy and Safety of Eribulin in the Treatment of HR+/HER2- Advanced Breast Cancer

Drug: Eribulin

HER2+ advanced breast cancer

Efficacy and Safety of Eribulin and anti-HER2 Targeted therapy in the Treatment of HER2+ advanced breast cancer

Drug: Eribulin; Drug: Trastuzumab; Drug: pertuzumab; Drug: Pyrotinib

triple negative advanced breast cancer

Efficacy and Safety of Eribulin and Immunotherapy in the Treatment of triple negative advanced breast cancer

Drug: Eribulin; Drug: Pembrolizumab; Drug: Camerlizumab

Interventions

Eribulin DRUG

Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle

Also known as: Halaven

HER2+ advanced breast cancer; HR+/HER2- advanced breast cancer; triple negative advanced breast cancer

Trastuzumab DRUG

Trastuzumab，8mg/kg for the first dose，6mg/kg for the following dose，Intravenous infusion，3-week cycle

Also known as: Herceptin

HER2+ advanced breast cancer

pertuzumab DRUG

Pertuzumab，，840mg for the first dose，420mg for the following dose，Intravenous infusion，3-week cycle

Also known as: Perjeta

HER2+ advanced breast cancer

Pyrotinib DRUG

Pyrotinib，400mg，oral，every day

HER2+ advanced breast cancer

Pembrolizumab DRUG

Pembrolizumab，200mg，Intravenous infusion，3-week cycle

Also known as: Keytruda

triple negative advanced breast cancer

Camerlizumab DRUG

Camerlizumab，200mg，Intravenous infusion，3-week cycle

triple negative advanced breast cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat Sen Memorial Hospital，Sun Yat sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 31087564 BACKGROUND

• 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.

  PMID: 29594360 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.

  PMID: 29716585 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Trastuzumab; pertuzumab; pyrotinib; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)