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Clinical Trials in China / NCT04547907
Recruiting Phase 3

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

NCT04547907 · tracked via the Priya Life Science China tracker
Sponsor
Henan Cancer Hospital
Phase
Phase 3
Started
2020-09-18
Last updated
2024-09-20

Condition(s) studied

Breast Cancer,HER2-positive

Investigational drug(s) / intervention(s)

Nab-paclitaxel+ trastuzumab+ patuzumabAll Nab-paclitaxel trials (139) →All Trastuzumab trials (76) →Docetaxel+ carboplatin+ trastuzumab + patuzumabAll Paclitaxel trials (419) →All Carboplatin trials (346) →All Trastuzumab trials (76) →

Nab-paclitaxel+ trastuzumab+ patuzumab: Nab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.

Docetaxel+ carboplatin+ trastuzumab + patuzumab: Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Henan cancer hospital Zhengzhou Henan Recruiting

More Henan Cancer Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04547907 on ClinicalTrials.gov ↗ ← All trials in China