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Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05357417
Recruitment Status : Recruiting
First Posted : May 2, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: utidelone Drug: Bevacizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases: A Multicenter, Single Arm, Open Label, Phase II Trial
Actual Study Start Date : April 29, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: cohort 1
HER2-negative advanced breast cancer with brain metastases who have received at least one prior anthracycline and one prior taxane
Drug: utidelone
30mg/m2 (±10%), day 1-5 every 3-week cycle

Drug: Bevacizumab
15mg/kg, day 1

Experimental: cohort 2
HER2-positive advanced breast cancer with brain metastases who have failed trastuzumab and pyrotinib
Drug: utidelone
30mg/m2 (±10%), day 1-5 every 3-week cycle

Drug: Bevacizumab
15mg/kg, day 1




Primary Outcome Measures :
  1. CNS-ORR according to the RECIST 1.1. [ Time Frame: up to 2 years ]
    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


Secondary Outcome Measures :
  1. CNS-ORR according to RANO criteria [ Time Frame: up to 2 years ]
    the proportion of patients with the best intracranial response of confirmed complete or partial response according to RANO criteria, as assessed by the investigator

  2. CNS-PFS assessed by investigator [ Time Frame: up to 2 years ]
    time from the first dose to disease progression or any-cause death

  3. extracranial ORR [ Time Frame: up to 2 years ]
    proportion of patients with confirmed extracranial complete or partial response per RECIST 1·1

  4. extracranial PFS [ Time Frame: up to 2 years ]
    time from the first dose to disease progression or any-cause death

  5. OS [ Time Frame: Estimated up to 3 year ]
    time from the first dose of study drug to any-cause death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05357417


Contacts
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Contact: Min Yan 15713857388 ym200678@126.com
Contact: Huimin Lv lvhuimin999@163.com

Locations
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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Min Yan, Professor    +86 15713857388    ym200678@126.com   
Principal Investigator: Min Yan, Professor         
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Principal Investigator: Min Yan Henan Cancer Hospital
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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT05357417    
Other Study ID Numbers: HNCH-MBC08-BM02
First Posted: May 2, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after de-identification are available following article publication.
Supporting Materials: Study Protocol
Time Frame: Three years from publication
Access Criteria: Please contact Central contact person by Email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henan Cancer Hospital:
brain metastases;bevacizumab;utidelone
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors