AzTrials
AzTrials

Breast CancerPhase 2NCT05357417

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

A Phase 2 study testing utidelone and Bevacizumab in people with Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
utidelone and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
29 Apr 2022to May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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；
  • Presence of unhealed wound, active ulcer or untreated fracture;
  • Any other condition inappropriate for this study deemed by the investigator.

Trial locations and contacts

1 site in 1 country.

Min Yan contact

15713857388

ym200678@126.com

Huimin Lv contact

lvhuimin999@163.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Min Yan, Professor, +86 15713857388, ym200678@126.com

    Min Yan, Professor

    Recruiting

Other trials in China

About this study

Official title: Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases: A Multicenter, Single Arm, Open Label, Phase II Trial

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.

Read the detailed description

This is a multicenter,open label, phase 2 trial to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases. Patients with HER2-negative advanced breast cancer who have received at least one prior anthracycline and one prior taxane or HER2-positive advanced breast cancer who have failed trastuzumab and pyrotinib, and with at least one measurable CNS lesion are eligible for the study.

This study includes 2 cohorts, and the Simon two-stage design are applied, respectively. A total of 48 patients with HER2-negative advanced breast cancer are included in cohort 1, and 52 patients with HER-2 positive patients are enrolled in cohort 2. Patients in both cohorts receive bevacizumab, 15mg/kg, day 1, and utidelone, 30mg/m2 (±10%), day 1-5 every 3-week cycle until disease progression or unmanageable toxicity. The primary endpoint is CNS-ORR according to the RECIST 1.1. The secondary endpoints include CNS-ORR according to RANO criteria, CNS-PFS assessed by investigator, extracranial ORR, extracranial PFS, OS, time to WBRT, quality of life and safety profile according to NCI-CTCAE 5.0.

Conditions
Breast Cancer
Being tested
utidelone, Bevacizumab
Keywords
brain metastases;bevacizumab;utidelone
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • utideloneDrug

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

  • BevacizumabDrug

    15mg/kg, day 1

Study groups in NCT05357417
Study groupRoleWhat they receive
cohort 1ExperimentalHER2-negative advanced breast cancer with brain metastases who have received at least one prior anthracycline and one prior taxane
Receives: Drug: utidelone; Drug: Bevacizumab
cohort 2ExperimentalHER2-positive advanced breast cancer with brain metastases who have failed trastuzumab and pyrotinib
Receives: Drug: utidelone; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 2 years

Secondary outcomes (5)

  1. CNS-ORR according to RANO criteria

    the proportion of patients with the best intracranial response of confirmed complete or partial response according to RANO criteria, as assessed by the investigator

    Measured: up to 2 years

  2. CNS-PFS assessed by investigator

    time from the first dose to disease progression or any-cause death

    Measured: up to 2 years

  3. extracranial ORR

    proportion of patients with confirmed extracranial complete or partial response per RECIST 1·1

    Measured: up to 2 years

  4. extracranial PFS

    time from the first dose to disease progression or any-cause death

    Measured: up to 2 years

  5. OS

    time from the first dose of study drug to any-cause death

    Measured: Estimated up to 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start29 Apr 2022
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05357417
Sponsor's protocol ID
HNCH-MBC08-BM02
Status last verified
Apr 2022
First submitted
21 Apr 2022
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identification are available following article publication.

Publications

  • 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.

    PubMed 40569584

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing utidelone and Bevacizumab in people with Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Min Yan (15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CNS-ORR according to the RECIST 1.1. (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05357417, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in