Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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; 2. 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; 3. Previously treated with at least one anthracycline and one taxane (as neoadjuvant therapy, adjuvant therapy, palliative therapy, or both); 4. Patients in cohort 2 have failed trastuzumab and pyrotinib treatment; 5. Prior unproven treatment progression with utidelone or bevacizumab; 6. ECOG PS of 0-1 and life expectancy exceeding 12 weeks; 7. 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; 8. Neurological lesions must be < grade 2 according to NCI CTCAE version 5.0 within four weeks before enrollment; 9. Without major organ dysfunction or heart disease; 10. Those of childbearing potential should use appropriate contraception before and during study period.

Exclusion Criteria:

1. Patients with leptomeningeal metastases who are not adequately treated by dehydration, hormone therapy, or urgently need radiotherapy; 2. Presence of effusions that cannot be controlled by drainage or other treatment (e.g., massive pericardial, thoracic, or abdominal effusions); 3. 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; 4. Participation in another clinical trial within four weeks before enrollment; 5. History of grade 3 or 4 allergic events to bevacizumab or utidelone; 6. Contraindications to MRI gadolinium-based contrast agents, such as pacemakers, shrapnel or intraocular foreign bodies; 7. Other malignancies within three years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma; 8. More than two seizures within four weeks before enrollment; 9. Insufficiently controlled hypertension, or history of hypertensive crisis or hypertensive encephalopathy; 10. CNS hemorrhage of grade 2 or higher within 12 months before enrollment; 11. NYHA class II or severe congestive heart failure, or history of myocardial infarction or unstable angina within six months; 12. History of hemoptysis within six months before enrollment, or evidence of bleeding tendency or significant coagulation dysfunction within one month; 13. Receiving full dose of warfarin or equivalent currently, or using aspirin (325 mg/day) within ten days; 14. Needs for major surgery, open biopsy or with major trauma within 28 days or during the study period; 15. History of abdominal fistula or gastrointestinal perforation within six months; 16. Presence of unhealed wound, active ulcer or untreated fracture; 17. Any other condition inappropriate for this study deemed by the investigator.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05357417
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Henan Cancer Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Min Yan
Principal Investigator Affiliation Henan Cancer Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer
Additional Details

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.

Arms & Interventions

Arms

Experimental: cohort 1

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

Experimental: cohort 2

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

Interventions

Drug: - utidelone

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

Drug: - Bevacizumab

15mg/kg, day 1

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan,

Site Contact

Min Yan, Professor

ym200678@126.com

+86 15713857388

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