Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Neoplasm Metastasis

Brain Neoplasms

Mammary Neoplasms, Animal

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Etoposide

Etoposide phosphate

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.

Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.MRI of the brain with contrast enhancement was performed at baseline and every 6 weeks after enrollment; thereafter, patients with stable disease or a response could be assessed at a reduced frequency to every 9 weeks; central nervous system and noncentral nervous system lesions were assessed according to RANO-BM criteria and RECIST v1.1 criteria until disease progression, respectively.

eutidrone etoposide bevacizumab

Yehui Shi, MD,Phd

Yehui Shi

This study was a single-arm, open-label, phase II study of breast cancer patients with brain metastases. Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.

The natural survival time of breast cancer patients with brain metastases is short and the prognosis is poor. Although the treatment is progressing, but it is still limited. The current domestic guidelines still recommend local therapy as a priority treatment strategy. At the same time, about 80% of patients with brain metastasis will progress to extracranial metastasis, so superior systemic treatment is particularly important, but very lacking.Therefore, new systematic therapeutic drugs are urgently needed .Eutiderone is a new generation of epirubicin anti-tumor drug with good efficacy and safety. In pre-clinical studies, it has been shown that the drug concentration in most tissues is higher than that in plasma, and the concentration of eutiderone in brain tissue is higher, indicating that the drug is easy to cross the blood-brain barrier.

The Efficacy and Safety of Eutideron, Etoposide, and Bevacizumab in Patients With Brain Metastases From Breast Cancer.

A Single-arm, Open-label， Phase Ⅱ Clinical Trial of Eutideron, Etoposide Combined With Bevacizumab for Breast Cancer Patients With Brain Metastases

The proportion of patients with complete response (CR) and partial response (PR) evaluated as the best response observed from enrollment to progression of all CNS target lesions assessed according to RANO-BM criteria among the total number of patients who could be evaluated.

Percentage of patients who achieved complete response (CR), partial response (PR), or stable disease (SD) in all CNS target lesions assessed by RANO-BM criteria within 12 weeks.

Time from enrollment to the first radiographic documented disease progression (PD) of all CNS target lesions (RANO-BM criteria) or death from any cause without progression was recorded.

Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions

Time from enrollment to the first radiographically confirmed disease progression (PD) (RECIST 1.1 criteria) or death from any cause without documented progression

Time from the enrollment to death of any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Efficacy and Safety of Eutideron, Etoposide, and Bevacizumab in Patients With Brain Metastases From Breast Cancer.	NCT05781633	Mammary Neoplas...	eutidrone etopo...	18 Years - 80 Years	Tianjin Medical University Cancer Institute and Hospital
The Efficacy and Safety of Eutideron, Etoposide, and Bevacizumab in Patients With Brain Metastases From Breast Cancer.	NCT05781633	Mammary Neoplas...	eutidrone etopo...	18 Years - 80 Years	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for eutidrone etoposide bevacizumab