This is a phase II trial to explore the efficacy and safety of weekly utidelone in HER2-negative inoperable locally advanced or metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Utidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days
Progression free survival (PFS)
PFS is defined as the duration from enrollment to the first radiologically confirmed progressive disease (PD) (RECIST 1.1 criteria) or death due to any cause.
Time frame: Estimated 12 months
Objective response rate (ORR)
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria
Time frame: Estimated 12 months
Overall Survival (OS)
From enrollment to death (for any reason)
Time frame: Estimated 24 months
Duration of Response (DOR)
The first evaluation of CR or PR to progression or death (for any reason)
Time frame: Estimated 12 months
Overall summary of adverse events following intravenous administration of utidelone (safety analysis set)
Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\[ Time Frame: 1 years\] Observe and record incidence of adverse events and severe adverse events associated with utidelone treatment, assessed by investigators according to CTCAE version 5.0.
Time frame: Estimated 12 months
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