A Prospective Phase Ⅱ Clinical Study of Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer That Has Failed Trastuzumab Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is a single-center, single-arm, prospective phase II clinical study, which mainly evaluates the efficacy and safety of pyrotinib maleate combined with oral vinorelbine in the treatment of HER2-positive advanced breast cancer.
详细描述
The most important treatment for HER2-positive breast cancer is based on anti-HER2 targeted therapy, combined with chemotherapy or endocrine therapy. China's original new anti-HER2 targeted therapy drug, pyrotinib, has obtained rapid approval from the country for its outstanding phase II clinical trial efficacy. In patients enrolled in the phase II trial, pyrotinib has a significant effect, but the combination of pyrotinib and capecitabine significantly increases the adverse reactions of diarrhea. For this reason, there is a lack of research on other combination schemes of pyrotinib in HER2 advanced breast cancer. In the first-line treatment, the combination therapy (HN) of trastuzumab and vinorelbine has shown that it also has a synergistic effect with vinorelbine in anti-HER2 targeted therapy. It provides a good evidence-based basis for the trial design of pyrotinib combined with vinorelbine soft capsules. This phase II clinical study is specially designed for preliminary exploration.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between 18 and 75 years old;
- •ECOG physical status score 0-2 points;
- •The expected overall survival period is not less than 12 weeks;
- •Pathologically confirmed HER2 expression-positive recurrent/metastatic breast cancer patients; the standard for HER2 expression positive is immunohistochemical staining (IHC) detection of HER2 3+ and/or fluorescent in situ hybridization (FISH) positive The researcher of the test center reviews and confirms).
- •The disease progresses during or after treatment with trastuzumab (stopping the drug for less than 12 months);
- •The number of chemotherapy lines used in the recurrence/metastasis stage is less than or equal to 2 lines;
- •Patients who have at least one measurable lesion [spiral CT scan ≥10 mm (CT scan thickness not greater than 5mm)] and who have progressed after or during the last anti-tumor treatment (RECIST version 1.1);
- •The main organs are functioning normally, that is, they meet the following standards:
- •The standard of routine blood examination should meet: Hb≥100 g/L (no blood transfusion within 14 days); ANC≥1.5×109 /L; PLT≥75×109 /L; 2) The biochemical inspection shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Serum creatinine ≤1.5×ULN, creatinine clearance ≥50ml/min (based on Cockroft and Gault formula); 3) Heart color Doppler ultrasound Left ventricular ejection fraction (LVEF) ≥50%;
- •For female patients who have not undergone menopause or have not undergone surgical sterilization: during treatment and at least 7 months after the last dose in the study treatment, agree to abstain from sex or use an effective method of contraception.
- •Patients voluntarily join this study, have good compliance with the planned treatment, understand the research process of this study, and sign written informed consent.
排除标准
- •There is fluid in the third space that cannot be controlled by drainage or other methods, such as pleural fluid and ascites;
- •There are many factors that affect the oral and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
- •Severe heart disease or discomfort, including but not limited to the following diseases:
- •Confirmed history of heart failure or systolic dysfunction (LVEF <50%)
- •High-risk uncontrolled arrhythmia, such as atrial tachycardia, resting heart rate> 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (ie Mobitz II second degree atrioventricular block or third degree atrioventricular block)
- •Angina pectoris that requires anti-angina pectoris medication
- •Clinically significant heart valve disease
- •ECG shows transmural myocardial infarction -Poor hypertension control (systolic blood pressure> 180 mmHg and/or diastolic blood pressure> 100 mmHg).
- •Those who have been confirmed to be allergic to the drug components of this program; have a history of immunodeficiency, including positive HIV testing, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- •Patients who are known to be pregnant or planning to become pregnant, or patients of gestational age who are unwilling to take effective contraceptive measures during the entire trial period;
- •Suffer from serious concomitant diseases, such as infectious diseases.
- •Other malignant tumors have occurred in the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- •Patients who have participated in other experimental studies within 30 days before the first dose of study drug is administered;
- •Patients judged by the investigator to be unsuitable to participate in this study.
研究组 & 干预措施
Pyrotinib plus Vinorelbine
干预措施: Pyrotinib Maleate (Drug)
Pyrotinib plus Vinorelbine
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Estimated 24 months
From enrollment to progression or death (for any reason)
次要结局
- Objective response rate (ORR)(Estimated 24 months)
- Disease Control Rate (DCR)(Estimated 24 months)
- Overall survival (OS)(Estimated 36 months)
- Security (CTCAE 5.0)(From informed consent through 28 days following treatment completion)