NCT03254654已完成2 期
A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN Trail)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
详细描述
A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN trail)
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Performance Status 0-1
- •Life expectancy longer than 3 months
- •Histological proven unresectable recurrent or advanced breast cancer
- •Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+)
- •Patients must have progressed after 1 or 2 prior chemotherapy regimens for metastatic disease, and consistent with the following treatment failure definition: progress in the first-line or second-line regimen treatment, or follow-up disease progression less than 3 months after completion of their last dose
- •At least one extracranial measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
- •Radiation therapy within 4 weeks prior to enrollment
- •All patients enrolled are required to have adequate hematologic, hepatic, and renal function
- •Be able to understand the study procedures and sign informed consent
排除标准
- •Patients had prior treatment with vinorelbine
- •Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
- •Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
- •Treatment with an investigational product within 4 weeks before the first treatment
- •Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
- •Uncontrolled serious infection
- •Unhealed wound or bone fracture
- •Patients with hypertension and uncontrolled hypertension with hypotensive drugs therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg). Patients with grade I or above myocardial ischemia or myocardial infarction or arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency
- •Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
- •Coagulation disorders (PT > 16 s, APTT > 43 s, TT > 21 s, Fbg < 2g / L) Being treated with thrombolytic or anticoagulant therapy, with bleeding tendency or definite gastrointestinal bleeding concerns (eg: local active ulcer lesions, fecal occult blood + + or above)
- •Artery or venous thrombosis occurred within 6 months before the study begins, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism, etc.
- •Patient who has a history of psychotropic substance abuse and is unable to stop or have a history of mental disorders
- •Have received prior treatment with a VEGFR TKI (Bevacizumab is permitted)
- •Another malignancy within 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma
研究组 & 干预措施
Vinorelbine Plus Apatinib
Experimental
Vinorelbine: 20 mg/m2, D6, D13, D20
Apatinib: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
干预措施: Vinorelbine (Drug)
Vinorelbine Plus Apatinib
Experimental
Vinorelbine: 20 mg/m2, D6, D13, D20
Apatinib: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
干预措施: Apatinib (Drug)
Vinorelbine
Active Comparator
Vinorelbine: 25 mg/m2, D1, D8, D15
干预措施: Vinorelbine (Drug)
结局指标
主要结局
PFS
时间窗: 6 weeks
Progression Free Survival
次要结局
- OS(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)
- ORR(6 weeks)
- Safety: Number of Participants with Adverse Events(6 weeks)
研究者
Xichun Hu
Vice Director of department of medical oncology
Fudan University
研究点 (1)
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