The Real World Study of First Line Treatment of HER2 Positive Recurrent/Metastatic Breast Cancer With Inetetamab Combined With Paclitaxel With/Without Pertuzumab（INTPOWER）
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- PFS
研究概览
简要总结
This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 - 70 years, female
- •Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
- •Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
- •Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
- •Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
- •ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;
- •The cardiopulmonary function is basically normal, with LVEF ≥ 50%;
- •Adequate organ function;
- •Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；
- •The patient voluntarily signs an informed consent form.
排除标准
- •Participated in other clinical trials within 4 weeks;
- •Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
- •During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
- •Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment;
- •Evidence of central nervous system metastasis or leptomeningeal disease;
- •Individuals with a known history of allergies to the components of this medication regimen;
- •Pregnant or lactating women;
- •Left ventricular ejection fraction<50% for cardiac function; Patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease;
- •The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.
研究组 & 干预措施
Inetetamab and Paclitaxel ± Pertuzumab
Inetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
Pertuzumab：was administered as an intravenous (IV) loading dose of 840mg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420mg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
干预措施: Inetetamab and Paclitaxel ± Pertuzumab (Drug)
结局指标
主要结局
PFS
时间窗: Until progression, assessed up to approximately 24 months
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
次要结局
- Objective Response Rate (ORR)(Until progression, assessed up to approximately 24 months)
- Clinical Benefit Rate (CBR)(Until progression or death, assessed up to approximately 24 months)
- Overall Survival (OS)(Up to approximately 3 years)
- Number of Participants With Adverse Events (AEs)(Up to approximately 3 years)
研究者
Jian Zhang,MD
Director of Phase I Clinical Trial Department; Professor, Chief physician of oncology department
Fudan University