Actively Recruiting
A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates
Led by Sun Yat-sen University · Updated on 2026-04-09
52
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer. Participants in this study have already tried other treatments like T-DXd or SG, but their cancer has gotten worse, and there are currently no standard treatment options left for them. Researchers believe that using these two drugs together may work better than using either one alone based on how they target cancer cells. The goal is to offer a new choice and help improve survival for these patients.
CONDITIONS
Official Title
A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older with metastatic or locally advanced unresectable breast cancer
- HER2-negative status confirmed by recent testing
- Prior treatment with anthracycline- or taxane-based chemotherapy
- Disease progression or intolerance after antibody-drug conjugate treatment, with no new treatments started since
- Received up to 4 prior lines of chemotherapy
- At least one measurable lesion by RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate major organ function as defined by blood counts and liver, kidney tests
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during and 8 weeks after treatment
- Able and willing to provide informed consent and complete follow-up
You will not qualify if you...
- Untreated active brain metastases; stable or treated brain metastases allowed
- Known spinal cord compression or active CNS metastases untreated or unstable
- HER2-positive breast cancer by recent testing
- Significant cardiovascular, liver, lung, kidney, blood, endocrine or neuropsychiatric diseases
- Active hepatitis B or C infection
- Anti-tumor monoclonal antibody therapy within 4 weeks or unresolved adverse reactions from prior therapies
- Known bleeding disorders
- Any condition that may interfere with study participation or results
- Severe underlying disease, comorbidity, or active infection
- Concurrent anti-tumor treatments
- History of epilepsy or seizure risk
- Pregnant or breastfeeding
- Poor compliance or inability to complete follow-up
- Known allergy to study drugs
- Diagnosis of another cancer within 3 years except certain treated non-melanoma skin, cervical, prostate, or breast conditions
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun yat-Sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
M
Meiting Chen, Doctor
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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