Actively Recruiting
Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer
Led by Seoul National University Hospital · Updated on 2025-11-20
180
Participants Needed
1
Research Sites
436 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Optimal salvage treatment for HER2-positive breast cancer after trastuzumab and T-DM1 failure still remains to be established. We would like to investigate the efficacy and safety of combination chemotherapy of eribulin and trastuzumab as salvage treatment for HER2-Positive breast cancer after exposure to trastuzumab and T-DM1
CONDITIONS
Official Title
Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Breast cancer that is unresectable or metastatic
- Confirmed HER2 positive expression as per central laboratory guidelines
- Previously treated with trastuzumab, T-DM1 or T-Dxd, and taxane
- Less than 4 prior lines of chemotherapy or HER2 targeted therapies for metastatic disease
- Documented radiologic progression during or after most recent treatment or within 6 months after adjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Male and female subjects of reproductive potential agree to use effective contraception during and 4.5 months after study treatment
- Adequate hematopoietic function (granulocyte count ≥1,500/mm3, platelet ≥100,000/mm3, hemoglobin ≥10g/mm3)
- Adequate hepatic function (total bilirubin ≤2.0 mg/dL, AST/ALT ≤2 x UNL, alkaline phosphatase ≤2.5 x UNL, or ≤5 x UNL if bone metastases)
- Adequate renal function (serum creatinine ≤1.5 mg/dL)
- Left ventricular ejection fraction of 50% or more
- CNS metastasis allowed if asymptomatic or controlled and non-progressing at entry
- Negative pregnancy test for premenopausal patients
- Ability to understand and comply with protocol
- Provided written informed consent
You will not qualify if you...
- Prior treatment with eribulin
- Uncontrolled or significant cardiovascular disease
- History of congestive heart failure or systolic dysfunction (LVEF <50%)
- High-risk uncontrolled arrhythmias
- Angina pectoris requiring medication
- Clinically significant valvular heart disease
- Evidence of transmural infarction on ECG
- Poorly controlled hypertension (systolic >180 mm Hg or diastolic >100 mm Hg)
- Pregnant or lactating women or women of childbearing potential not using contraception
- History of cancer other than certain non-invasive or skin cancers, unless disease-free for over 2 years
- GI tract diseases causing inability to take oral medication or malabsorption
- Active hepatic or biliary disease (with some exceptions)
- Serious medical disorders or infections preventing consent or participation
- Known hypersensitivity to study drugs or their ingredients
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Seock-Ah Im, MD,PhD
CONTACT
K
Kyunghun Lee, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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