Actively Recruiting
Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
Led by Henan Cancer Hospital · Updated on 2026-04-16
79
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
H
Henan Cancer Hospital
Lead Sponsor
Q
Qilu Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Female aged 18 to 70 years
- At least 2 prior treatment lines
- Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer
- Prior failure of taxanes and/or anthracyclines, or progression after at least one line of endocrine therapy for hormone receptor-positive HER2-negative breast cancer
- Eastern Cooperative Oncology Group (ECOG) score 0 to 2 and life expectancy of at least 3 months
- At least one measurable lesion by RECIST 1.1 criteria
- Adequate blood, liver, and kidney function
- Recovery to grade 1 or less toxicity from prior anticancer therapy
- Women of childbearing potential must agree to use effective contraception during the study and for 6 months after treatment; non-lactating and negative pregnancy test within 7 days prior to enrollment
You will not qualify if you...
- Progression on prior Bevacizumab treatment
- Previous use of Utidelone within 6 months
- Less than 3 weeks since radiotherapy or chemotherapy, or less than 1 week since endocrine therapy
- Clinically significant bleeding or bleeding tendency within 3 months prior to enrollment
- History of arteriovenous thrombotic events within 6 months prior to enrollment
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Recent major cardiovascular events within 6 months
- Interstitial lung disease, pneumonitis, or uncontrolled systemic diseases
- Renal insufficiency with significant proteinuria
- Recent live attenuated vaccine within 28 days before first dose or planned vaccination during study
- HIV infection or active hepatitis B or C infection
- Severe infection within 4 weeks before treatment
- Any other malignancy diagnosed within 3 years
- Major surgery within 28 days or minor surgery within 14 days before enrollment
- History of allogeneic bone marrow or solid organ transplantation
- Peripheral neuropathy grade 2 or higher
- Active brain metastases or certain central nervous system diseases
- Pregnancy, lactation, or plans to become pregnant during the study
- Serious physical or mental illness or abnormal lab findings that increase risk or interfere with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
M
Min Yan
CONTACT
M
Mengwei Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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