A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

Summary

The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

Eligibility

Inclusion Criteria:

1. Age: 18-70 years;
2. Clinical T2-T4d, or T1c with axillary lymph node positivity;
3. Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay；
4. Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
5. No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:

   1. Neutrophil count absolute value ≧2.0×109/L;
   2. Hemoglobin ≧ 100g/L;
   3. Platelet count ≧100×109/L;
   4. Total bilirubin \<1.5 ULN (upper limit of normal);
   5. Creatinine \< 1.5×ULN
   6. AST/ALT \< 1.5×ULN;
6. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);
7. Reproductive age women, negative serum pregnancy test within 14 days before randomization;
8. ECOG score 0 or 1;
9. Signature of informed consent.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer;
2. Bilateral breast cancer;
3. Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
4. Patients with a second primary malignancy, except for adequately treated skin cancer;
5. Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures;
6. Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following:

   1. History of heart failure or systolic dysfunction (LVEF \< 50%);
   2. High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-grade atrioventricular conduction blocks (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);
   3. Angina pectoris requiring anti-anginal drug therapy;
   4. Clinically significant valvular heart disease;
   5. ECG showing a transmural myocardial infarction;
   6. Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg);
7. Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated;
8. Known history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or a history of organ transplantation.

Conditions3

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