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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer

Randomized, Open Label, Multi-Center, Phase II Trial of Eribulin With or Without SB3 (Trastuzumab-biosimilar) in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens

Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer (NCT05530057) is a Phase 2 interventional studying Advanced Breast Cancer, sponsored by Seoul National University Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Advanced Breast Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 180 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Breast Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults ≥18 years old. - Pathologically documented breast cancer that: - is unresectable or metastatic - has confirmed HER2 positive expression (immunohistochemistry or FISH) as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory - was previously treated with trastuzumab, T-DM1 or T-Dxd, and taxane (whether in recurrent/metastatic setting or neoadjuvant/adjuvant setting). - Less than 4 prior lines of chemotherapy or HER2 targeted therapies for treatment in metastatic disease (\<4 treatment regimens for recurrent/metastatic disease excluding adjuvant treatments) - Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy). - Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 - Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study treatment. - Adequate hematopoietic, renal and hepatic functions. - Adequate hematopoietic function: Absolute granulocyte count ≥1,500/mm3, platelet count at least 100,000/mm3, blood count (hemoglobin) at least 10g/mm3 - Adequate hepatic function: total bilirubin ≤2.0mg/dL, AST/ALT ≤2 x UNL, alkaline phosphatase ≤2.5 x UNL, in case with bone metastases alkaline phosphatase ≤5 x UNL - Adequate renal function: Serum creatinine ≤1.5mg/dL - a left ventricular ejection fraction of 50% or more (determined by echocardiography or multiple-gated acquisition \[MUGA(Multigated Blood Pool Scan)\] scanning) - CNS(central nervous system) metastasis is permitted if asymptomatic or controlled with minimal steroid requirement and is documented to be non-progressing at study entry. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adults ≥18 years old. * Pathologically documented breast cancer that: * is unresectable or metastatic * has confirmed HER2 positive expression (immunohistochemistry or FISH) as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory * was previously treated with trastuzumab, T-DM1 or T-Dxd, and taxane (whether in recurrent/metastatic setting or neoadjuvant/adjuvant setting). * Less than 4 prior lines of chemotherapy or HER2 targeted therapies for treatment in metastatic disease (\<4 treatment regimens for recurrent/metastatic disease excluding adjuvant treatments) * Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy). * Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 * Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study treatment. * Adequate hematopoietic, renal and hepatic functions. * Adequate hematopoietic function: Absolute granulocyte count ≥1,500/mm3, platelet≥100,000/mm3, hemoglobin≥10g/mm3 * Adequate hepatic function: total bilirubin ≤2.0mg/dL, AST/ALT ≤2 x UNL, alkaline phosphatase ≤2.5 x UNL, in case with bone metastases alkaline phosphatase ≤5 x UNL * Adequate renal function: Serum creatinine ≤1.5mg/dL * a left ventricular ejection fraction of 50% or more (determined by echocardiography or multiple-gated acquisition \[MUGA(Multigated Blood Pool Scan)\] scanning) * CNS(central nervous system) metastasis is permitted if asymptomatic or controlled with minimal steroid requirement and is documented to be non-progressing at study entry. * Negative result for urine or serum pregnancy tests within the screening period in premenopausal patients * Ability to understand and comply with protocol during study period * Patients should sign a written informed consent before study entry Exclusion Criteria: * Prior treatment with eribulin * Uncontrolled or significant cardiovascular disease * History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF \<50%) * High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade Atrioventricular-block, supraventricular arrhythmias, prolonged QTc(corrected QT interval) which are not adequately rate-controlled) * Angina pectoris requiring antianginal medication * Clinically significant valvular heart disease * Evidence of transmural infarction on ECG * Poorly controlled hypertension (e.g. systolic \>180mm Hg or diastolic \>100mm Hg) * Pregnant or lactating women or women of childbearing potential, including women whose last menstrual period was ,12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during the study treatment period. * Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer and thyroid cancer. For other types of cancer, patients could be included if there is no evidence of disease for more than 2 years. * Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis) * Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) * Concurrent disease or serious medical disorder, for example, active or uncontrolled infection, interstitial lung disease (ILD) or any psychiatric condition prohibiting understanding or rendering of informed consent. * Patients who have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients.

Treatments Being Tested

DRUG

Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar)

* Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle and SB3 8 mg/kg I.V. over 90 minutes on day 1 of cycle 1 . Thereafter, SB3 6 mg/kg will be infused over 30 minutes on day 1 of each subsequent 21-day cycle until progression or unacceptable toxicity. * Dose reductions for eribulin, but not for SB3, is permitted. * Two dose reductions (1.1, 0.7 mg/m2) are allowed for eribulin before consideration of study treatment discontinuation. Eribulin could be continued as monotherapy if trastuzumab-similar was discontinued, and vice-versa.

DRUG

Eribulin Mesylate

* Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle until progression or unacceptable toxicity. * Two dose reductions (1.1, 0.7 mg/m2) are allowed before consideration of study treatment discontinuation.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Seoul National University Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05530057), the sponsor (Seoul National University Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05530057 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05530057?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05530057?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05530057. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05530057. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.