HER-2 Negative Breast CancerPhase 2NCT05398861
Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
A Phase 2 study testing utidelone injection and Bevacizumab in people with HER-2 Negative Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER-2 Negative Breast Cancer
- What is being tested?
- utidelone injection and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2022to 30 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form;
- Women aged 18-70 years;
- The number of treatment lines for patients ≥ 2 lines;
- Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:
- Patients with HER2-negative breast cancer who have failed previous treatment with taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who have progressed after at least one line of previous endocrine drug therapy;
- Eastern Cooperative Oncology Group (ECOG) score [0-2] points,Life expectancy of not less than 3 months;
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- At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST1.1);
- Adequate hematological, hepatic and renal function;
- Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior anticancer therapy;
- Women of childbearing age must agree to use highly effective methods of contraception during the study and within 6 months after administration of the study drug; Subjects must be non-lactating and have a negative serum or urine pregnancy test within 7 days prior to study enrollment
Who cannot join
- Patients who have progressed on prior bevacizumab;
- Patients who have previously used Utidelone, and the interval is less than 6 months from the end of medication;
- Less than 3 weeks after radiotherapy or chemotherapy; less than 1 week after endocrine therapy;
- Concomitant diseases/medical history; (1)Clinically significant hemoptysis (with daily hemoptysis of more than 50 ml) within 3 months before enrollment; or clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood or greater at baseline, or suffering from vasculitis; (2)Patients with arteriovenous thrombotic events within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis (except resolved venous thrombosis caused by previous chemotherapy, which has been judged by the investigator) and pulmonary embolism; (3)Hypertension not adequately controlled with antihypertensive therapy (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg); Randomization occurs within 6 months as follows: myocardial infarction, severe/unstable angina, NYHA Class 2 or greater, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure (4)Interstitial lung disease, pneumonitis, or uncontrollable systemic disease (e.g., diabetes, pulmonary fibrosis, acute pneumonitis, etc.; (5)Renal insufficiency: urine routine showed urine protein ≥ + +, or 24 h urine protein ≥ 1.0g was confirmed; (6)History of attenuated live vaccine within 28 days before the first dose of study drug or anticipated vaccination with live attenuated vaccines during the study (7)Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C; (8)Presence of severe infection within 4 weeks before administration, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. Active infection with CTCAE 5.0 ≥ grade 2 requiring systemic antibiotic therapy within 2 weeks before the first dose, or unexplained fever > 38.5 ° C during the screening period/before the first dose (fever due to tumor causes may be included if judged by the investigator); evidence of active tuberculosis infection within 1 year before dosing.
- Any other malignancy diagnosed within 3 years before study entry;
- Major surgery within 28 days and minor surgery within 14 days before enrollment;
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- Patients who have previously received or are ready to receive allogeneic bone marrow transplantation or solid organ transplantation;
- Peripheral neuropathy ≥ grade 2; active brain metastases, carcinomatous meningitis, spinal cord compression, or brain or leptomeningeal disease found by CT or MRI at screening (patients with brain metastases who have completed treatment on 14 days before enrollment and have stable symptoms, however, it needs to be confirmed as no cerebral hemorrhage symptoms by brain MRI, CT or venography evaluation);
- Female patients who are pregnant, lactating, or plan to become pregnant during the study;
- Patients who have other serious physical or mental illness or abnormal laboratory findings that may increase the risk of study participation, or interfere with study results, and are not suitable for this study in the opinion of the investigator;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Min Yan, +86 15713857388, ym200678@126.com
Min Yan
About this study
Official title: A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
This study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.
Read the detailed description
Patients included were patients with ≥ 2 lines of HER2-negative advanced breast cancer who had previously failed taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who had progressed after at least 1 line of prior endocrine therapy.
This study used a Simon two-stage design. 71 subjects will be enrolled using the optimal design.
- Conditions
- HER-2 Negative Breast Cancer
- Being tested
- utidelone injection, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utidelone injectionDrug
Also called UTD1
Utidelone: 30 mg/m2/day, IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle Bevacizumab:10mg/kg (IV), on day 1 of each 21 days.
BevacizumabDrug
Bevacizumab: 10mg/kg, administered on day 1 of each cycle, with a treatment cycle lasting 21 days;
| Study group | Role | What they receive |
|---|---|---|
| HER-2 Negative Advanced Breast Cancer | Experimental | Utidelone Combined with Bevacizumab Receives: Drug: utidelone injection; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator
Measured: up to 2 years
Secondary outcomes (4)
Objective response rate (ORR)
Percentage of patients with a best investigator-assessed response of CR or PR from enrollment until disease progression as assessed by RECIST 1.1 compared with the total number of evaluable patients.
Measured: up to 2 years
Overall survival (OS)
OS is defined as the duration of time from first study treatment until death from any cause.
Measured: up to 3 years
Duration Of Response(DOR)
The assessment is conducted every two cycles. DOR is used to measure the time from the first occurrence of complete remission (CR) or partial remission (PR) in patients to the onset of disease progression (PD) or death due to any cause.
Measured: up to 2 years
Adverse Events(AEs)
An assessment is conducted once for each visit cycle.During each visit, all adverse events and laboratory indicators must be fully documented.
Measured: The research period lasts for two years, and the evaluation will continue until the completion of the research.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start19 Aug 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Qilu Pharmaceutical Co., Ltd., Beijing Biostar Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398861
- Sponsor's protocol ID
- HNCH-MBC11
- Status last verified
- Apr 2026
- First submitted
- 22 May 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05398861
- Acronym / sponsor ID
- HNCH-MBC11
- Conditions
- HER-2 Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Qilu Pharmaceutical Co., Ltd., Beijing Biostar Pharmaceuticals Co., Ltd.
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 1 Jun 2022 (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 is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.
Detailed description
Patients included were patients with ≥ 2 lines of HER2-negative advanced breast cancer who had previously failed taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who had progressed after at least 1 line of prior endocrine therapy.
This study used a Simon two-stage design. 71 subjects will be enrolled using the optimal design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER-2 Negative Advanced Breast Cancer | Experimental | Drug: utidelone injection, Drug: BevacizumabUtidelone Combined with Bevacizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed Informed Consent Form;
- Women aged 18-70 years;
- The number of treatment lines for patients ≥ 2 lines;
- Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:
- Patients with HER2-negative breast cancer who have failed previous treatment with taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who have progressed after at least one line of previous endocrine drug therapy;
Key exclusion criteria (10 listed)
- Patients who have progressed on prior bevacizumab;
- Patients who have previously used Utidelone, and the interval is less than 6 months from the end of medication;
- Less than 3 weeks after radiotherapy or chemotherapy; less than 1 week after endocrine therapy;
- Concomitant diseases/medical history; (1)Clinically significant hemoptysis (with daily hemoptysis of more than 50 ml) within 3 months before enrollment; or clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood or greater at baseline, or suffering from vasculitis; (2)Patients with arteriovenous thrombotic events within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis (except resolved venous thrombosis caused by previous chemotherapy, which has been judged by the investigator) and pulmonary embolism; (3)Hypertension not adequately controlled with antihypertensive therapy (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg); Randomization occurs within 6 months as follows: myocardial infarction, severe/unstable angina, NYHA Class 2 or greater, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure (4)Interstitial lung disease, pneumonitis, or uncontrollable systemic disease (e.g., diabetes, pulmonary fibrosis, acute pneumonitis, etc.; (5)Renal insufficiency: urine routine showed urine protein ≥ + +, or 24 h urine protein ≥ 1.0g was confirmed; (6)History of attenuated live vaccine within 28 days before the first dose of study drug or anticipated vaccination with live attenuated vaccines during the study (7)Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C; (8)Presence of severe infection within 4 weeks before administration, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. Active infection with CTCAE 5.0 ≥ grade 2 requiring systemic antibiotic therapy within 2 weeks before the first dose, or unexplained fever > 38.5 ° C during the screening period/before the first dose (fever due to tumor causes may be included if judged by the investigator); evidence of active tuberculosis infection within 1 year before dosing.
- Any other malignancy diagnosed within 3 years before study entry;
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 |
|---|---|---|
| utidelone injectionAlso: UTD1Utidelone: 30 mg/m2/day, IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle Bevacizumab:10mg/kg (IV), on day 1 of each 21 days. | Drug | HER-2 Negative Advanced Breast Cancer |
| BevacizumabBevacizumab: 10mg/kg, administered on day 1 of each cycle, with a treatment cycle lasting 21 days; | Drug | HER-2 Negative Advanced Breast Cancer |
Primary outcome
Progression free survival (PFS)
Time frame: up to 2 years
PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator
4 secondary outcomes
Objective response rate (ORR)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 3 years
Duration Of Response(DOR)
Time frame: up to 2 years
Adverse Events(AEs)
Time frame: The research period lasts for two years, and the evaluation will continue until the completion of the research.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing utidelone injection and Bevacizumab in people with HER-2 Negative 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 10 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Yan (+86 15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (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?
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 Apr 2026.