NCT07057427招募中3 期
Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 812
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L
- •Hemoglobin ≥ 100 g/L
- •Platelet count ≥ 100 × 10⁹/L
- •Total bilirubin < 1.5 × upper limit of normal (ULN)
- •Serum creatinine < 1.5 × ULN
- •Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < 1.5 × ULN
- •Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 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
- •Informed consent: Provision of signed written informed consent.
排除标准
- •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:
- •History of congestive heart failure or systolic dysfunction (LVEF < 50%)
- •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])
- •Angina pectoris requiring anti-anginal medication
- •Clinically significant valvular heart disease
- •Electrocardiogram (ECG) evidence of transmural myocardial infarction
- •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.
研究组 & 干预措施
Nab-PHP group
Experimental
Nab-paclitaxel(on days 1 and 8 of a 21-day cycle) + trastuzumab+ patuzumab (every 3 weeks)
干预措施: Nab paclitaxel (Drug)
Nab-PHP group
Experimental
Nab-paclitaxel(on days 1 and 8 of a 21-day cycle) + trastuzumab+ patuzumab (every 3 weeks)
干预措施: Trastuzumab + Pertuzumab (Drug)
TCbHP
Active Comparator
Docetaxel + carboplatin + trastuzumab + patuzumab (every 3 weeks)
干预措施: Docetaxel and Carboplatin (Drug)
TCbHP
Active Comparator
Docetaxel + carboplatin + trastuzumab + patuzumab (every 3 weeks)
干预措施: Trastuzumab + Pertuzumab (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: through study completion, up to 6 months
次要结局
- Invasive Disease-Free Survival (iDFS)(5 years after surgery)
- Event-Free Survival (EFS)(5 years after surgery)
- Safety-Number of adverse events and serious adverse events.(up to 1 year)
- Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs(up to 1 year)
- Residual Cancer Burden (RCB)(up to 6 months)
- EORTC QLQ-C30 score(up to 1 year)
- EORTC QLQ-BR23 score(up to 1 year)
研究者
Zhenzhen Liu
Professor
Henan Cancer Hospital
研究点 (1)
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