A Multicenter Clinical Study of Apatinib Mesylate in Combination With a Physician's Choice Regimen for Her-2 Negative, HR-positive Progressive Breast Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- Progression-free survival
研究概览
简要总结
Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2 negative, HR-positive advanced breast cancer.
详细描述
In order to further explore the efficacy of apatinib mesylate in advanced breast cancer with negative her-2 and positive HR, this study intends to carry out an observation study on the efficacy of apatinib mesylate combined with doctor's choice scheme in the treatment of advanced breast cancer with negative her-2 and positive HR.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Received radiation therapy within 28 days prior to enrollment. Radiotherapy for the relief of metastatic bone pain prior to enrollment is permitted, provided that no more than 30% of the total marrow-containing bone is irradiated, with the exception of patients with good bone feel prior to treatment;
- •The presence of evidence of central nervous system metastases;
- •Current or recent (within 30 days prior to enrollment) use of another investigational drug or participation in another clinical study
- •Other malignancy within 5 years (except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or controlled basal cell carcinoma of the skin)
- •Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacologic therapy)
- •Myocardial ischemia or myocardial infarction of class II or greater, poorly controlled arrhythmias (including qtc intervals ≥450 ms in men and ≥470 ms in women);
- •Grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound suggesting left ventricular ejection fraction (LVEF) <50%;
- •Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or under thrombolytic or anticoagulant therapy;
- •Have had clinically significant bleeding symptoms or a definite bleeding tendency within the previous 3 months, such as gastrointestinal bleeding, bleeding gastric ulcer, fecal occult blood +++ or more at baseline, or have vasculitis
- •Have undergone major surgical procedures or have sustained a severe traumatic injury, fracture, or ulcer within the previous 4 weeks
- •Having factors that significantly affect the absorption of oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction, etc;
- •Urine routine suggestive of urinary protein ≥ ++, or confirmed 24-hour urine protein volume ≥ 1.0 g;
- •Plasmapheresis (including pleural fluid, ascites, and pericardial effusion) that is clinically symptomatic and requires surgical management;
- •Other conditions that, in the judgment of the investigator, may affect the conduct of the clinical study and the determination of the study results.
研究组 & 干预措施
Apatinib mesylate combined with chemotherapy (Capecitabine/vinorelbine)
干预措施: apatinib mesylate+Capecitabine Tablets (Drug)
Apatinib mesylate combined with endocrine
干预措施: apatinib mesylate+Fulvestrant injection (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 36 months
Progression-free survival
次要结局
未报告次要终点
研究者
Li Huiping
Director of breast oncology department
Peking University Cancer Hospital & Institute