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Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer

StatusRecruiting
PhasePhase 2
Started2022-08-19
View on ClinicalTrials.gov ↗

Amendment history

2026-04-13
Not Yet Recruiting→Recruiting Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-12-30→2026-12-30
Completion date2024-12-30→2027-05-30
Start dateestimated 2022-06-01→confirmed 2022-08-19
Enrollment target71→79
InterventionsUtidelone Combined with Bevacizumab (Drug)→Bevacizumab (Drug), utidelone injection (Drug)
Secondary endpoints2 to 4 entries
ProgressionObjective freeresponse survivalrate (PFSORR) Duration Of Response（DOR） Adverse Events（AEs）
Primary endpoints1 entry, revised
ObjectiveProgression responsefree ratesurvival (ORRPFS)
2022-05-26
Original filing
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.
Trial Details
NCT Number NCT05398861
Lead Sponsor Henan Cancer Hospital
Collaborators: Qilu Pharmaceutical Co., Ltd., Beijing Biostar Pharmaceuticals Co., Ltd.
Conditions HER-2 Negative Breast Cancer
Enrollment 79 participants
Start Date 2022-08-19
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-16