The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- PFS
研究概览
简要总结
Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients
Research purpose:
Main research objectives:
To observe the efficacy and safety of pyrrolidine in the treatment of HER2 positive advanced first-line breast cancer.
Secondary research objectives:
- Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes)
- Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment
- To observe the efficacy of pyrrolitinib in patients with brain metastasis of HER2 positive breast cancer
Research endpoint:
Main research endpoint:
Progression free survival (rwPFS)
Secondary study endpoint:
Efficacy endpoints: objective response rate (rwORR), disease control rate (rwDCR), until treatment failure Time to Flight (TTF), Total Survival (OS), Security
详细描述
Overall Study Design: This study adopts a prospective, multicenter, and observational design, with a planned enrollment of 500 first-line patients who plan to receive pyrrolitinib treatment for HER2 positive patients. The medication regimen is not restricted, Fully follow the clinical choices of doctors and evaluate the clinical benefits of using different modes of pyrrolitinib (PFS) and security. The imaging evaluation is based on the RECIST 1.1 standard and is conducted by reference to the The research center conducts tumor efficacy evaluation. Patients using pyrrolitinib need to undergo a safety visit on the 28th day of the last administration, and thereafter Enter survival follow-up until patient death or trial termination (whichever occurs first).
Administration method: Pyrrolitinib standard dose: 400 mg once a day, oral administration within 30 minutes after breakfast, continuous administration for 21 days per cycle. The dosage can be determined by the doctor according to the actual situation Make adjustments. Other medications: The doctor selects the medication plan based on the actual situation.
Inclusion criteria:
- Age ≥ 18 years old;
- Pathological or histopathological confirmed HER2 positive cases cannot be surgically advanced or metastasized Patients with sexual breast cancer (HER2 positive is defined as: standard immunohistochemistry (IHC) Detected as 3+or ISH positive);
- There is a traceable medical history record during the treatment period;
- Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.
Exclusion criteria:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Pathological or histopathological confirmed HER2 positive cases cannot be surgically advanced or metastasized Patients with sexual breast cancer (HER2 positive is defined as: standard immunohistochemistry (IHC) Detected as 3+or ISH positive);
- •There is a traceable medical history record during the treatment period;
- •Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.
排除标准
- •Failure to sign informed consent form;
- •Previous history of other malignant tumors, but cured skin basal cell carcinoma and cervical cancer Excluding cancer;
- •Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can affect medication administration and absorption Various factors;
- •Pregnant or lactating women, and women of childbearing age who cannot achieve optimal contraception;
- •Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
研究组 & 干预措施
Pyrotinib
干预措施: Pyrotinib (Drug)
结局指标
主要结局
PFS
时间窗: 24.3months
The time from randomization to disease progression evaluated by researchers for patients
次要结局
未报告次要终点