Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2 Positive Operable Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2 Positive Operable Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
At present, trastuzumab combined with patuzumab has become the standard neoadjuvant therapy
 for high-risk HER2 positive breast cancer. TCbHP has been the standard choice of neoadjuvant
 therapy for HER2 positive breast cancer patients with early high-risk or locally advanced
 HER2 positive breast cancer. Whether nab-PHP can achieve the same effect as TCbHP is still
 uncertain.
Inclusion Criteria:

 1. 18 years ≤ age ≤ 75 years, Performance Status- Eastern Cooperative Oncology Group
 (ECOG) 0-1

 2. Clinical T2-T4d, or T1c with axillary LN+

 3. HER2 + invasive breast cancer confirmed by histopathology Note: HER2 expression
 positive refers to the tumor cells with immunohistochemical staining intensity of 3 +
 or confirmed positive by fluorescence in situ hybridization [fish] at least once
 during the pathological detection/review of primary tumor in the Department of
 pathology of participating research center hospital

 4. Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum
 target or MR (optional) within 1 month before randomization

 5. Organ and bone marrow function test within one month before chemotherapy showed no
 chemotherapy contraindication

 -  Absolute value of neutrophil count ≥ 2.0×10^9 / L

 -  Hemoglobin ≥ 100g / L

 -  Platelet count ≥ 100×10^9 / L

 -  Total bilirubin < 1.5 ULN (upper limit of normal value)

 -  Creatinine < 1.5 × ULN

 -  AST/ALT < 1.5×ULN

 6. Echocardiography: left ventricular ejection fraction (LVEF ≥ 55%)

 7. For women of childbearing age, serum pregnancy test was negative 14 days before
 randomization

 8. KPS score ≥ 80 points

 9. Signed the informed consent form prior to patient entry

 Exclusion Criteria:

 1. Metastatic disease (Stage IV)

 2. Chemotherapy, endocrine therapy, targeted therapy and reflexotherapy have been used
 for this disease

 3. The patient had a second primary malignant tumor, except for the well treated skin
 cancer

 4. Patients who had undergone major surgery unrelated to breast cancer within 4 weeks
 before enrollment, or had not recovered completely from such operations

 5. Serious heart disease or discomfort, including but not limited to the following
 diseases:

 -  History of heart failure or systolic dysfunction (LVEF < 50%)

 -  high risk uncontrolled arrhythmias such as atrial tachycardia, resting heart rate
 > 100 BPM, significant ventricular arrhythmias (e.g., ventricular tachycardia) or
 higher-level atrioventricular block (i.e., mobitz II second degree
 atrioventricular block or third degree atrioventricular block)

 -  angina pectoris requiring anti angina drugs

 -  Heart valve disease with clinical significance

 -  ECG showed transmural myocardial infarction

 -  Poor control of hypertension (systolic blood pressure > 180 mmHg and / or
 diastolic blood pressure > 100 mmHg)

 6. Due to serious and uncontrollable other medical diseases, the researchers believe that
 there are chemotherapy contraindications

 7. Those who have been known to have allergic history to the drug components of this
 regimen; have a history of immune deficiency, including HIV positive test, or have
 other acquired or congenital immunodeficiency diseases, or have a history of organ
 transplantation;