About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Informed Consent Form;
Women aged 18-70 years;
The number of treatment lines for patients ≥ 2 lines;
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;
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
utidelone injection
DrugUtidelone: 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.
Bevacizumab
DrugBevacizumab: 10mg/kg, administered on day 1 of each cycle, with a treatment cycle lasting 21 days;
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Overall survival (OS)
OS is defined as the duration of time from first study treatment until death from any cause.
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.
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.
Sponsors and contacts
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Henan Cancer Hospital
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator
Beijing Biostar Pharmaceuticals Co., Ltd.
Collaborator