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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer

The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer (NCT06641544) is a Phase 4 interventional studying Metastatic Breast Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. 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

This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of 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 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Metastatic 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: - Female patients aged ≥ 18 years and ≤ 70 years old; - Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive); - Invasive breast cancer confirmed by pathological examination, with evidence of local recurrence or imaging metastasis, and those with local recurrence must be confirmed by the researcher as unable to undergo radical surgery; - Have not received first-line anti-HER2 treatment or (new) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months; - ECOG PS score 0-2, expected survival period ≥ 6 months, and able to follow up; - According to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there must be at least one clearly measurable and/or assessable lesion present, and the lesion diameter evaluated by CT or MRI must be ≥ 1cm; - In the absence of blood transfusion or pharmacological treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to the first treatment, and organ function must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; platelets (PLT) ≥ 90×10\^9/L; hemoglobin (Hb) ≥ 90g/L. Blood biochemistry: total bilirubin (TBIL) ≤1.5×ULN,known as Gilbert syndrome patients, TBIL ≤ 2 × ULN; ALT and AST ≤2.5×ULN; and liver metastasis patients require ALT and AST ≤5×ULN; Alkaline phosphatase ≤ 2.5 × ULN; BUN and Cr ≤1.5×ULN; - Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal, unless drugs known to alter INR and APTT are used; - Left ventricular ejection fraction (LVEF) ≥50%; - 12 lead electrocardiogram: Fridericia corrected QT interval (QTcF)\<470msec; - No history of major organs such as the heart, lungs, liver, kidneys, or endocrine system; ...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: * Female patients aged ≥ 18 years and ≤ 70 years old; * Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive); * Invasive breast cancer confirmed by pathological examination, with evidence of local recurrence or imaging metastasis, and those with local recurrence must be confirmed by the researcher as unable to undergo radical surgery; * Have not received first-line anti-HER2 treatment or (new) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months; * ECOG PS score 0-2, expected survival period ≥ 6 months, and able to follow up; * According to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there must be at least one clearly measurable and/or assessable lesion present, and the lesion diameter evaluated by CT or MRI must be ≥ 1cm; * In the absence of blood transfusion or pharmacological treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to the first treatment, and organ function must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; platelets (PLT) ≥ 90×10\^9/L; hemoglobin (Hb) ≥ 90g/L. Blood biochemistry: total bilirubin (TBIL) ≤1.5×ULN,known as Gilbert syndrome patients, TBIL ≤ 2 × ULN; ALT and AST ≤2.5×ULN; and liver metastasis patients require ALT and AST ≤5×ULN; Alkaline phosphatase ≤ 2.5 × ULN; BUN and Cr ≤1.5×ULN; * Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal, unless drugs known to alter INR and APTT are used; * Left ventricular ejection fraction (LVEF) ≥50%; * 12 lead electrocardiogram: Fridericia corrected QT interval (QTcF)\<470msec; * No history of major organs such as the heart, lungs, liver, kidneys, or endocrine system; * Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures; * Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up. Exclusion Criteria: * Have received other clinical study drugs within 4 weeks prior to the first study drug administration; * Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage); * During the (new) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab, pertuzumab, and pyrotinib; * Patients who experience disease progression during (new) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (new) adjuvant system treatment; * Evidence of symptomatic central nervous system metastasis or leptomeningeal disease (patients with brain metastases who have received radiation therapy and have been stable for ≥ 4 weeks can be enrolled); * Patients with only bone or skin as the sole target lesion; * Serious heart disease or discomfort, including but not limited to the following situations: 1. History of heart failure or systolic dysfunction (LVEF\<50%); 2. High risk or treatable angina pectoris or arrhythmia (such as second degree type 2 atrioventricular block or third degree atrioventricular block, ventricular tachycardia); 3. Clinically significant heart valve disease; 4. Electrocardiogram indicates transmural myocardial infarction; 5. Uncontrolled hypertension (excluding stable cases where systolic blood pressure\>150 mmHg and/or diastolic blood pressure\>90 mmHg can be controlled after stable treatment); * Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers); * Presence of active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive and HCV RNA above the upper limit of normal range), and cirrhosis; * History of immunodeficiency, including HIV infection, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; * There is a third fluid accumulation (such as pleural effusion or ascites) that cannot be controlled by drainage or other methods; * Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that are not suitable for participation in this study, such as pulmonary infections that require treatment; * Other malignant tumors within the past five years, except for those cured of cervical, basal cell carcinoma, and squamous cell carcinoma; * The patient has undergone major surgical procedures or significant trauma within the first 4 weeks of randomization, or is expected to undergo major surgical treatment; * Peripheral neuropathy of grade ≥ 3 judged according to CTCAE 5.0 standards; * Those who are known to have a history of allergies to the components of this drug regimen; * Researchers determine that individuals are not suitable for receiving systemic chemotherapy; * Pregnant or lactating female patients who are unable to use effective contraception throughout the entire trial period and are of childbearing age; * The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.

Treatments Being Tested

DRUG

Inetetamab

Group A received Inetetamab+Pertuzumab+TPC, while Group B received Inetetamab+Pyrotinib+TPC.

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.

Sun Yat sen Memorial Hospital of Sun Yat sen University Shenzhen Shantou Central Hospital
Shanwei, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06641544), the sponsor (Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University), 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 NCT06641544 clinical trial studying?

This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06641544?

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 NCT06641544?

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 NCT06641544. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06641544. 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 2026-06-07 · Data from ClinicalTrials.gov.