Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast cancer. It is available in oral form, making it convenient to use and an ideal choice for rhythmic chemotherapy. In advanced breast cancer,metronomic oral vinorelbine chemotherapy has been the subject of several clinical studies, with proven effectiveness and good safety, showing great prospects for application.
Considering the current lack of targeted, efficient, and convenient drugs for HER2-negative advanced breast cancer in later lines of treatment, and based on the preliminary efficacy of metronomic oral vinorelbine, anlotinib, and rhythmic chemotherapy in breast cancer, we plan to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with anlotinib in the treatment of HER2-negative advanced breast cancer, providing new data for the treatment of HER2-negative advanced breast cancer.
详细描述
Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative advanced breast cancer.
Study Drugs - metronomic oral vinorelbine: 30mg/capsule, 20mg/capsule - Anlotinib: 12mg/capsule, 10mg/capsule, 8mg/capsule
Research Objective To determine the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast cancer, and to provide new data for later-line treatment of HER2-negative advanced breast cancer.
Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 60 patients.
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
- 未提供
排除标准
- •Patients who have previously received treatment with vinorelbine and/or anlotinib;
- •Patients with active or untreated brain metastasis;
- •Patients who have had or currently have other malignancies within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades basement membrane)];
- •Patients who have undergone major surgery (including thoracotomy biopsy) or suffered a significant trauma (such as bone fracture) within 4 weeks before randomization, have unhealed wounds or fractures at the time of screening, or are expected to undergo major surgery during the study period;
- •Patients with a history of myocardial infarction within the past 6 months; history of congestive heart failure with New York Heart Association (NYHA) classification ≥ II, or severe arrhythmia (excluding atrial fibrillation and paroxysmal supraventricular tachycardia) that cannot be controlled by medication;
- •Patients with known allergies to the drugs and their excipients involved in this trial;
- •Patients with a known history of hypersensitivity reactions to any investigational drugs;
- •Patients who are simultaneously participating in other trials;
- •Patients who cannot evaluate the efficacy of the treatment plan with existing technology;
- •Patients judged unsuitable for participation by other investigators.
研究组 & 干预措施
Label 1
metronomic oral vinorelbine plus anlotinib
干预措施: metronomic oral vinorelbine plus anlotinib (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
It is an indicator of the long-term efficacy of the drug.
次要结局
- Overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Objective Response Rate(4 weeks)
- Disease Control Rate(4 weeks)
研究者
Yan Xue
Director of tumor hospital
Xi'an International Medical Center Hospital