Mammary Neoplasms, HumanNCT05781633
The Efficacy and Safety of Eutideron, Etoposide, and Bevacizumab in Patients With Brain Metastases From Breast Cancer.
A study testing eutidrone etoposide bevacizumab in people with Mammary Neoplasms, Human, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Mammary Neoplasms, Human
- What is being tested?
- eutidrone etoposide bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 20 Jul 2025
- Phase
- Interventional
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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：
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- 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.
Who cannot join
- 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.
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- 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.
- Any brain lesion deemed to require immediate local treatment, including (but not limited ) increased lesion size at anatomical sites or possible treatment-related edema, may pose a risk to the patient (e.g.brain stem lesions). Patients received local treatment were still eligible for study based on lesions identified by screening contrast brain MRI according to the criteria described in the CNS inclusion criteria.
- 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.
- Known or suspected allergies to any of the study drugs or excipients.
- No brain MRI for any reason.
- Any other condition considered by the investigator to be unsuitable for participation in the trial.
- Other situations in which corticosteroid use is prohibited.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yehui Shi
Tianjin, Tianjin Municipality, 300060
Yehui Shi, 18622221183, shiyehui@tjmuch.com
About this study
Official title: A Single-arm, Open-label， Phase Ⅱ Clinical Trial of Eutideron, Etoposide Combined With Bevacizumab for Breast Cancer Patients With Brain Metastases
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.
Read the detailed description
The natural survival time of breast cancer patients with brain metastases is short and the prognosis is poor. Although the treatment is progressing, but it is still limited. The current domestic guidelines still recommend local therapy as a priority treatment strategy. At the same time, about 80% of patients with brain metastasis will progress to extracranial metastasis, so superior systemic treatment is particularly important, but very lacking.Therefore, new systematic therapeutic drugs are urgently needed .Eutiderone is a new generation of epirubicin anti-tumor drug with good efficacy and safety. In pre-clinical studies, it has been shown that the drug concentration in most tissues is higher than that in plasma, and the concentration of eutiderone in brain tissue is higher, indicating that the drug is easy to cross the blood-brain barrier.
- Conditions
- Mammary Neoplasms, Human
- Being tested
- eutidrone etoposide bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eutidrone etoposide bevacizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: eutidrone etoposide bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
CNS Clinical benefit rate(CNS-CBR)
Percentage of patients who achieved complete response (CR), partial response (PR), or stable disease (SD) in all CNS target lesions assessed by RANO-BM criteria within 12 weeks.
Measured: 3 months
CNS Progression-free survival (CNS-PFS)
Time from enrollment to the first radiographic documented disease progression (PD) of all CNS target lesions (RANO-BM criteria) or death from any cause without progression was recorded.
Measured: 36 months
Objective response rate (ORR)
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Measured: 12 months
Progression-free survival（PFS）
Time from enrollment to the first radiographically confirmed disease progression (PD) (RECIST 1.1 criteria) or death from any cause without documented progression
Measured: 36 months
Overall survival (OS)
Time from the enrollment to death of any cause
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start20 Jul 2022
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammary Neoplasms, HumanStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yehui Shi, MD,Phd, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781633
- Sponsor's protocol ID
- UTD-1-BM-II
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label， Phase Ⅱ Clinical Trial of Eutideron, Etoposide Combined With Bevacizumab for Breast Cancer Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT05781633
- Acronym / sponsor ID
- UTD-1-BM-II
- Conditions
- Mammary Neoplasms, Human
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The natural survival time of breast cancer patients with brain metastases is short and the prognosis is poor. Although the treatment is progressing, but it is still limited. The current domestic guidelines still recommend local therapy as a priority treatment strategy. At the same time, about 80% of patients with brain metastasis will progress to extracranial metastasis, so superior systemic treatment is particularly important, but very lacking.Therefore, new systematic therapeutic drugs are urgently needed .Eutiderone is a new generation of epirubicin anti-tumor drug with good efficacy and safety. In pre-clinical studies, it has been shown that the drug concentration in most tissues is higher than that in plasma, and the concentration of eutiderone in brain tissue is higher, indicating that the drug is easy to cross the blood-brain barrier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eutidrone+ etoposide+ bevacizumab | Experimental | Drug: eutidrone etoposide bevacizumabEligible 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eutidrone etoposide bevacizumabEligible 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. | Drug | eutidrone+ etoposide+ bevacizumab |
Primary outcome
CNS Objective response rate (CNS-ORR)
Time frame: 12 months
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.
5 secondary outcomes
CNS Clinical benefit rate(CNS-CBR)
Time frame: 3 months
CNS Progression-free survival (CNS-PFS)
Time frame: 36 months
Objective response rate (ORR)
Time frame: 12 months
Progression-free survival（PFS）
Time frame: 36 months
Overall survival (OS)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehui Shi, MD,Phd principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eutidrone etoposide bevacizumab in people with Mammary Neoplasms, Human, run by Tianjin Medical University Cancer Institute and 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 15 inclusion and 20 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 23 Mar 2023. 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.
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 Yehui Shi, MD,Phd (18622221183, shiyehui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS Objective response rate (CNS-ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2023.