Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2 Positive Operable Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Carboplatin; Docetaxel; Paclitaxel; Trastuzumab

Criteria

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;