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

NCT05781633 | Unknown

• 1 other identifier: UTD-1-BM-II
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mammary Neoplasms, Human

Outcome Measures

Primary Outcomes (1)

• CNS Objective response rate (CNS-ORR)

  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.

  12 months

Secondary Outcomes (5)

• CNS Clinical benefit rate(CNS-CBR)

  3 months

• CNS Progression-free survival (CNS-PFS)

  36 months

• Objective response rate (ORR)

  12 months

• Progression-free survival（PFS）

  36 months

• Overall survival (OS)

  36 months

Study Arms (1)

eutidrone+ etoposide+ bevacizumab

EXPERIMENTAL

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.

Drug: eutidrone etoposide bevacizumab

Interventions

eutidrone etoposide bevacizumab DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Female,\>18.
• Histologically or cytologically confirmed recurrent metastatic breast cancer.
• ECOG:0-2.
• There was at least one measurable lesion in the central nervous system.
• Based on screening brain magnetic resonance imaging (MRI), patients with CNS must meet one of the following conditions：
• Untreated brain metastases from breast cancer do not require immediate local treatment.
• Previously treated breast cancer brain metastases that have progressed after previous central nervous system local treatment as assessed by the investigator and that do not have clinical features requiring immediate local treatment.
• Previous anti-HER2 therapy and TKI therapy were required for HER2+ patients.
• Patients who had not received chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy within 4 weeks before enrollment.
• All toxicity in patients associated with previous antitumor therapy must be restored to ≤ grade 1 (CTCAE v5.0). However, patients with any grade of alopecia were allowed.
• Routine blood tests were normal within 1 week before enrollment (according to the normal range at the participating laboratory):White blood cell count (WBC) ≥ 3.0 × 109/L; Neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 100 × 109/L; Hemoglobin ≥ 9.0 g/dL; patients could receive blood transfusions or erythropoietin to meet this criterion.
• Liver and kidney function were basically normal within 1 week before enrollment (based on the normal values of the participating laboratory):Total bilirubin (TBIL) ≤ 2.5× upper limit of normal value (ULN); Alanine aminotransferase (SGPT/ALT) ≤2.5×ULN (≤5×ULN in patients with liver metastases); Aspartate aminotransferase (SGOT/AST) ≤2.5×ULN (≤5×ULN in patients with liver metastases); Creatinine clearance (Ccr) ≥60 ml/min
• Male or female patients of childbearing potential had to consent to use an effective method of contraception, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and up to 90 days after the last study medication was taken. Female patients of reproductive age had to have a negative blood or urine pregnancy test before enrollment.
• Life expectancy ≥ 12 weeks.

You may not qualify if:

• Other malignant tumors (including primary brain or leptomeningeal related tumors) within the past 5 years, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
• Previous anti-tumor therapy, including chemotherapy, radical radiotherapy, hormone therapy, biological therapy, immunotherapy or anti-tumor traditional Chinese medicine therapy within 4 weeks before initiation of study treatment.
• Patients had previously used eutidrone injection, etoposide, or bevacizumab.
• Patients had undergone major organ surgery (excluding needle biopsies) or major trauma within 4 weeks before the first dose of the study drug, or required elective surgery during the trial.
• Patients with ≥grade 3 neurosystem-related severe adverse reactions after previous use of anti-microtubules.
• Patients with any untreated \> 2.0cm brain injury, unless discussed with the investigator and approved for registration.
• Systemic corticosteroids were continued to control symptoms of brain metastases at a total daily dose of \>2mg dexamethasone (or equivalent). However, patients with chronic stable doses ≤2mg daily of dexamethasone (or equivalent) may be discussed and approved by the investigator.
• More than 2 seizures within 4 weeks before enrollment.
• Poor control of hypertension; Or a previous history of hypertensive crisis or hypertensive encephalopathy.
• Patients had a history of hemoptysis within 6 months before enrollment. Or evidence of bleeding tendency or significant coagulopathy within the past 1 month.
• Currently receiving full-dose warfarin or equivalent, or aspirin (325mg/ day) within 10 days
• The need for major surgery, open biopsy, or major trauma was anticipated within 28 days or during the course of the study.
• Patients with a history of abdominal fistula or gastrointestinal perforation within the previous 6 months; The presence of an unhealed wound, active ulcer, or untreated fracture; Pregnant or lactating women.
• Patients with a history of psychotropic drug abuse and inability to abstain or with mental disorders.
• Other nonmalignant systemic diseases (cardiovascular, renal, liver, etc.) that were treated by any treatment regimen or prevented follow-up were excluded.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Yehui Shi

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yehui Shi, MD,Phd

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yehui Shi, MD,Phd

CONTACT

18622221183; shiyehui@tjmuch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 23, 2023
• Study Start: July 20, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2025
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)