Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

NCT05357417 | Unknown Phase 2

• 1 other identifier: HNCH-MBC08-BM02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases, and thus provides a new systemic treatment strategy for those patients.

Conditions

Breast Cancer

Keywords

brain metastases;bevacizumab;utidelone

Outcome Measures

Primary Outcomes (1)

• CNS-ORR according to the RECIST 1.1.

  the proportion of patients with the best intracranial response of confirmed complete or partial response according to RECIST 1·1, as assessed by the investigator

  up to 2 years

Secondary Outcomes (5)

• CNS-ORR according to RANO criteria

  up to 2 years

• CNS-PFS assessed by investigator

  up to 2 years

• extracranial ORR

  up to 2 years

• extracranial PFS

  up to 2 years

• OS

  Estimated up to 3 year

Study Arms (2)

cohort 1

EXPERIMENTAL

HER2-negative advanced breast cancer with brain metastases who have received at least one prior anthracycline and one prior taxane

Drug: utidelone; Drug: Bevacizumab

cohort 2

EXPERIMENTAL

HER2-positive advanced breast cancer with brain metastases who have failed trastuzumab and pyrotinib

Drug: utidelone; Drug: Bevacizumab

Interventions

utidelone DRUG

30mg/m2 (±10%), day 1-5 every 3-week cycle

cohort 1; cohort 2

Bevacizumab DRUG

15mg/kg, day 1

cohort 1; cohort 2

Eligibility Criteria

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

You may qualify if:

• Aged ≥ 18 years; histologically or cytologically confirmed invasive breast cancer with metastatic disease; patients without pathologically or cytologically confirmed metastatic disease must have physical or radiological proof of metastasis;
• With measurable CNS disease, defined as at least one parenchymal brain lesion that can be accurately measured in at least one dimension by local radiology;
• Previously treated with at least one anthracycline and one taxane (as neoadjuvant therapy, adjuvant therapy, palliative therapy, or both);
• Patients in cohort 2 have failed trastuzumab and pyrotinib treatment;
• Prior unproven treatment progression with utidelone or bevacizumab;
• ECOG PS of 0-1 and life expectancy exceeding 12 weeks;
• Normal organ and bone marrow function; normal blood sample within one week before enrollment (as determined by the laboratory's normal values in each center), including WBC ≥ 3.0 x 109/L, ANC ≥ 1.5×109/L, PLT ≥ 100×109/L; normal kidney and liver function within one week before enrollment (as determined by the laboratory's normal values in each center), including TBIL ≤ 1.5 ULN, SGPT/ALT ≤ 2.5 ULN (≤ 5 ULN in patients with liver metastases), SGOT/AST ≤ 2.5 ULN, Ccr ≥ 60 ml/min;
• Neurological lesions must be \< grade 2 according to NCI CTCAE version 5.0 within four weeks before enrollment;
• Without major organ dysfunction or heart disease;
• Those of childbearing potential should use appropriate contraception before and during study period.

You may not qualify if:

• Patients with leptomeningeal metastases who are not adequately treated by dehydration, hormone therapy, or urgently need radiotherapy;
• Presence of effusions that cannot be controlled by drainage or other treatment (e.g., massive pericardial, thoracic, or abdominal effusions);
• Patients received WBRT, chemotherapy, major surgery, targeted therapy or immunotherapy within two weeks before enrollment, received endocrine therapy within one week before enrollment, or received nitrosourea or mitomycin based chemotherapy within six weeks before enrollment；
• Participation in another clinical trial within four weeks before enrollment；
• History of grade 3 or 4 allergic events to bevacizumab or utidelone;
• Contraindications to MRI gadolinium-based contrast agents, such as pacemakers, shrapnel or intraocular foreign bodies;
• Other malignancies within three years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma;
• More than two seizures within four weeks before enrollment;
• Insufficiently controlled hypertension, or history of hypertensive crisis or hypertensive encephalopathy;
• CNS hemorrhage of grade 2 or higher within 12 months before enrollment;
• NYHA class II or severe congestive heart failure, or history of myocardial infarction or unstable angina within six months;
• History of hemoptysis within six months before enrollment, or evidence of bleeding tendency or significant coagulation dysfunction within one month;
• Receiving full dose of warfarin or equivalent currently, or using aspirin (325 mg/day) within ten days;
• Needs for major surgery, open biopsy or with major trauma within 28 days or during the study period;
• History of abdominal fistula or gastrointestinal perforation within six months；

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Related Publications (1)

• Yan M, Lv H, Liu X, Wang S, Geng C, Song Y, Liu Z, Niu L, Zhang M, Wang C, Feng Y, Zeng H, Sun H, Wang J, Xiang Y, Tang L, Qiu R. Utidelone Plus Bevacizumab for ERBB2-Negative Metastatic Breast Cancer and Active Brain Metastases: The U-BOMB Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2025 Aug 1;11(8):883-889. doi: 10.1001/jamaoncol.2025.1694.

  PMID: 40569584 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab

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

Study Officials

• Min Yan

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Yan

CONTACT

15713857388; ym200678@126.com

Huimin Lv

CONTACT

lvhuimin999@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 2, 2022
• Study Start: April 29, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 16, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Three years from publication
• Access Criteria: Please contact Central contact person by Email

Locations

CN (1)