Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC

Inclusion criteria

• Signed informed consent.
• Age: Female patients aged 18-70 years.
• Breast cancer meeting the following criteria:
• Histologically confirmed invasive breast cancer, with primary tumor diameter ≥ 2.0 cm, Stage II-III as assessed by local standard methods.
• HER2-positive breast cancer, defined as Immunohistochemistry (IHC) score 3+ or In Situ Hybridization (ISH) showing HER2 gene amplification.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
• All required baseline laboratory tests and imaging studies completed before randomization.
• Adequate organ function
• For non-menopausal (amenorrhea \< 12 months) or non-surgically sterile female patients (without ovaries and/or uterus): Agreement to abstain or use reliable and effective contraception during treatment and for at least 6 months after the last dose of study treatment.
• Investigator judgment that the patient can comply with the study protocol.

Exclusion criteria

• Bilateral breast cancer or metastatic (Stage IV) breast cancer.
• Significant cardiac disease:
• History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the past 6 months.
• New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or history of NYHA Class III or IV CHF.
• High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block.
• Angina requiring anti-anginal medication.
• Clinically significant valvular heart disease.
• ECG evidence of transmural myocardial infarction.
• Other malignancies within the past 5 years, except cured carcinoma in situ of the cervix or non-melanoma skin cancer.
• Severe systemic infection or patients with other serious diseases.
• Major non-breast surgery within 4 weeks of randomization, or patients who have not fully recovered from such surgery.
• Known history of Human Immunodeficiency Virus (HIV) infection.
• Active hepatitis B or hepatitis C virus infection.
• Known allergy or intolerance to the study drugs or their excipients.
• Prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason.
• Currently enrolled in or previously participated in a study of an investigational drug and received investigational treatment or used an investigational device within 4 weeks before the first dose of study treatment (12 months for investigational drugs/devices with anti-cancer or anti-proliferative properties).
• Vaccination with a live vaccine within 30 days before the first dose of the investigational drug.
• Psychiatric illness or substance abuse history that could affect compliance with trial requirements.
• Pregnancy or breastfeeding, or female patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial.
• Patients judged by the investigator to be unsuitable for participation in this study.