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โ† Trials
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Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

RecruitingPhase 3Ages 18 Years - 70 YearsAllHenan Cancer Hospital
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Age: 18-70 years old. Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity. Histologically confirmed HER2-positive invasive breast cancer: Note: HER2 positivity is defined as at least one assessment (either initial testing or central review) by the participating center's pathology department demonstrating tumor cells with immunohistochemistry (IHC) staining intensity of 3+ or confirmation by fluorescence in situ hybridization (FISH). Clinically measurable disease: Lesion measurable by ultrasound or MRI (optional) within 1 month prior to randomization. Adequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy): 1. Absolute neutrophil count (ANC) โ‰ฅ 2.0 ร— 10โน/L 2. Hemoglobin โ‰ฅ 100 g/L 3. Platelet count โ‰ฅ 100 ร— 10โน/L 4. Total bilirubin \< 1.5 ร— upper limit of normal (ULN) 5. Serum creatinine \< 1.5 ร— ULN 6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \< 1.5 ร— ULN Cardiac function: Left ventricular ejection fraction (LVEF) โ‰ฅ 55% assessed by echocardiography. Women of childbearing potential: Negative serum pregnancy test within 14 days prior to randomization. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Informed consent: Provision of signed written informed consent. Exclusion Criteria: Stage IV (metastatic) breast cancer. Bilateral breast cancer. Prior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy. History of a second primary malignancy, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from prior major surgery. Significant cardiac disease or dysfunction, including but not limited to: 1. History of congestive heart failure or systolic dysfunction (LVEF \< 50%) 2. High-risk uncontrolled arrhythmias (e.g., atrial tachycardia, resting heart rate \> 100 bpm, clinically significant ventricular arrhythmia \[e.g., ventricular tachycardia\], or higher-grade atrioventricular block \[i.e., Mobitz II second-degree or third-degree heart block\]) 3. Angina pectoris requiring anti-anginal medication 4. Clinically significant valvular heart disease 5. Electrocardiogram (ECG) evidence of transmural myocardial infarction 6. Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) Presence of any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy. 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.
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What it tests

  • Nab paclitaxel
  • Docetaxel and Carboplatin
  • Trastuzumab + Pertuzumab
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Where

1 site
Henan cancer hospital
Zhengzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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