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

Sponsor
Henan Cancer Hospital
Study ID
NCT05398861
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HER-2 Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • utidelone injection — DRUG
    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.
  • Bevacizumab — DRUG
    Bevacizumab: 10mg/kg, administered on day 1 of each cycle, with a treatment cycle lasting 21 days;

Study Details

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.

Key Dates

First listed
Jun 1, 2022
Start date
Aug 19, 2022
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
May 30, 2027

Study Design

Enrollment
79 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HER-2 Negative Advanced Breast Cancer
    Utidelone Combined with Bevacizumab

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: up to 2 years ]

Central Contacts