Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with Pyrrotinib and Chemotherapeutic Agents in Neoadjuvant Therapy for HER2-positive Breast Cancer with Different Treatment Cycles

Launched by THE FIRST HOSPITAL OF JILIN UNIVERSITY · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with HER2-positive breast cancer, which is a type of breast cancer that is more aggressive and needs specific targeted therapies. The study aims to see how effective and safe a combination of medications—initumab, pyrrotinib, and chemotherapy—are when given before surgery (called neoadjuvant therapy). Participants will be divided into two groups: one group will receive the treatment for 4 cycles, and the other group for 6 cycles. After surgery, patients who show a complete response (meaning no signs of cancer) will continue the treatment for another year.

To be eligible for this trial, participants must be between 18 and 70 years old, have a confirmed diagnosis of invasive HER2-positive breast cancer, and meet certain health criteria, such as having a good heart function and no prior history of breast cancer. Participants can expect regular visits for treatment and monitoring, and they will be closely observed for any side effects. This trial is not yet recruiting, so it’s important for interested patients to stay informed about when it will begin.

Gender

ALL

Eligibility criteria

• • inclusion criteria：
• • 1. Age ≥18 years old, while ≤70 years old, gender is not limited; 2.2. Invasive breast cancer confirmed histologically by air-core needle biopsy; According to AJCC breast cancer Staging System 8th edition, clinical staging was T1c-4, N0-3, M0.
• • 3. HER2 positive: IHC 3+ or IHC 2+ and FISH+ 4.Left ventricular ejection fraction (LVEF) ≥ 50% 5.ECOG physical condition score is 0 or 1 6.In the absence of blood transfusion or symptomatic treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to initial administration, organ function must meet the following requirements Blood routine: absolute value of neutrophil (ANC) ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (Hb) ≥90g/L Blood biochemistry: Total bilirubin (TBIL) ≤1.5×ULN; ALT and AST≤1.5×ULN; BUN and Cr≤1.5×ULN; Creatinine clearance ≥50mL/min (Cockcroft-Gault formula) 7.Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up
• exclusion criteria:
• • 1. Previous history of invasive breast cancer
• • 2. Bilateral breast cancer, inflammatory breast cancer (e.g., erythema and/or skin involvement, and/or pathological findings of tumor cells in the dermal lymphatic vessels), or clinical stage T1c, N0, M0
• • 3. Prior biopsy of primary tumor and/or axillary lymph node excision and/or excision
• • 4. Previous systemic treatment for breast cancer;
• • 5. A history of life-threatening hypersensitivity, or a known history of allergy to any component of the investigational drug;
• • 6. Participated in clinical trials of other drugs or medical devices within 4 weeks before the first drug use, and received treatment with experimental drugs or devices
• • 7. Patients who had undergone major surgery within 28 days prior to the first dose or planned to undergo major surgery during the study period
• • 8. Other malignant tumors (excluding cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ) within the previous 5 years
• • 9. Active hepatitis, active tuberculosis or other serious infectious diseases, including but not limited to: Active hepatitis C virus (HCV) infection (HCV antibody positive but not RNA negative), or hepatitis B virus (HBV) infection (HBV surface antigen positive and HBV-DNA copy number \>2000 IU/mL) or other serious infections requiring systemic treatment such as bacteremia, severe infectious pneumonia
• • 10. A history of immunodeficiency or other autoimmune diseases, including but not limited to human immunodeficiency virus (HIV) infection (HIV-positive), systemic lupus erythematosus, rheumatoid arthritis, or a history of organ transplantation
• • 11. Patients with a history of cardiovascular and cerebrovascular diseases, including: (1) unstable angina pectoris; (2) medically treatable or clinically significant arrhythmias; (3) myocardial infarction occurring within 6 months; (4) Heart failure, degree II and above atrioventricular block; (5) Cerebral infarction (except lacunar cerebral infarction), cerebral hemorrhage and other diseases occurring within 6 months
• • 12. Patients with poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg under regular medication), or with a prior history of hypertensive crisis or hypertensive encephalopathy
• • 13. Pregnant and lactating female patients; Pregnant women of childbearing age who were positive in screening pregnancy test; Patients who are unwilling to use effective contraception throughout the trial period and for 6 months after the end of medication
• • 14. Other circumstances deemed inappropriate by the investigator to participate in the study