NCT05781633

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mammary Neoplasms, Human

Interventions

Type	Name	Description
DRUG	eutidrone etoposide bevacizumab	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.

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-07-20
• Completion: 2025-07-20
• First posted: 2023-03-23
• Last updated: 2023-03-23

Locations

1 site across 1 country: China