Comparing the Efficacy and Security of Nab-PHP and TCbHP in Neoadjuvant Chemotherapy for HER2 Positive Operable Breast Cancer , A Multicenter, Randomized, Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
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.
详细描述
In order to compare the effects of nab-PHP and TCBHP chemotherapy regimens in the neoadjuvant treatment of HER2-positive breast cancer, this study randomly divided patients who met the inclusion criteria into 2 groups through a randomized control regimen.
nab-PHP regimen：Albumin binding paclitaxel 125 mg / m2 (1, 8, 15 days) + trastuzumab (8 mg / kg for the first loading dose and 6 mg / kg for the sequential maintenance dose) + patuzumab (840mg for the first loading dose and 420mg for the sequential maintenance dose) ，every 21 days for 6 cycles.
TCbHP regimen：Docetaxel 75 mg/m2 + carboplatin (AUC = 6) + trastuzumab(8 mg / kg for the first loading dose and 6 mg / kg for the sequential maintenance dose) + patuzumab (840mg for the first loading dose and 420mg for the sequential maintenance dose) ，every 21 days for 6 cycles.
Finally, the safety and efficacy of the two chemotherapy regimens were evaluated by postoperative PCR, ORR, DFS, OS and number of adverse events.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ age ≤ 70 years, Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- •Clinical T2-T4d, or T1c with axillary LN+
- •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
- •Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum target or MR (optional) within 1 month before randomization
- •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
- •Echocardiography: left ventricular ejection fraction (LVEF ≥ 55%)
- •For women of childbearing age, serum pregnancy test was negative 14 days before randomization
- •ECOG score of 0 or 1
- •Signed the informed consent form prior to patient entry
排除标准
- •Metastatic breast cancer (Stage IV)
- •Chemotherapy, endocrine therapy, targeted therapy and reflexotherapy have been used for this disease
- •The patient had a second primary malignant tumor, except for the well treated skin cancer
- •Patients who had undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or had not recovered completely from such operations
- •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)
- •Due to serious and uncontrollable other medical diseases, the researchers believe that there are chemotherapy contraindications
- •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;
研究组 & 干预措施
nab-PHP
Nab-paclitaxel + trastuzumab+ patuzumab
干预措施: Nab-paclitaxel+ trastuzumab+ patuzumab (Drug)
TCbHP
Docetaxel + carboplatin + trastuzumab + patuzumab
干预措施: Docetaxel+ carboplatin+ trastuzumab + patuzumab (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: through study completion, an average of 1 year
Pathological Complete Response (pCR) rate: It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
次要结局
- Event-Free Survival (EFS)(5 years after surgery)
- Invasive Disease-Free Survival (iDFS)(5 years after surgery)
- Safety-Number of adverse events and serious adverse events.(After each cycle of chemotherapy (21 days as 1 cycle))
- Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs(After the end of the 6th cycle of chemotherapy (21 days as 1 cycle))
- Exploratory endpoint - Differences in pCR rates between predefined subgroups and factors influencing pCR in the study population.(through study completion, an average of 1 year)
研究者
Zhenzhen Liu
Director
Henan Cancer Hospital