Neoadjuvant Apatinib Added to Weekly Paclitaxel and Cisplatin in Patient With Locally Advanced or Early Stage HER2 Negative Breast Cancer (APP) : a Open-label, Randomized, Controlled, Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
研究概览
简要总结
RATIONALE:
The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer.
PURPOSE:
To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients
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
- •18~70 year-old，Female
- •Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
- •HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative.
- •Adequate organ function
排除标准
- •Unwilling to use adequate contraceptive protection during the process of the study and for at least 8 weeks after the last dose of study drug.
- •Pregnant or breastfeeding patients
- •Metastatic or recurrent patients
- •Any evidence of sense or motor nerve disorders
- •Any concurrent malignancy other than breast cancer
- •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
- •Artery or venous thrombosis occurred within 6 months before the study begins
- •Have received prior treatment with a VEGFR TKI
研究组 & 干预措施
Arm I
Apatinib+Paclitaxel+Cisplatin
干预措施: Cisplatin (Drug)
Arm I
Apatinib+Paclitaxel+Cisplatin
干预措施: Apatinib (Drug)
Arm I
Apatinib+Paclitaxel+Cisplatin
干预措施: Paclitaxel (Drug)
Arm I
Apatinib+Paclitaxel+Cisplatin
干预措施: Surgery (Procedure)
Arm II
Paclitaxel+Cisplatin
干预措施: Paclitaxel (Drug)
Arm II
Paclitaxel+Cisplatin
干预措施: Cisplatin (Drug)
Arm II
Paclitaxel+Cisplatin
干预措施: Surgery (Procedure)
结局指标
主要结局
Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
时间窗: Time of surgery
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.
Residual cancer burden (RCB 0-I rates）
时间窗: Time of surgery
RCB 0-I rates means RCB 0+I (good response) rates.
次要结局
- Number of Participants With Drug Related Treatment Adverse Events(an average of 16 weeks)
- Disease-free Survival (DFS)(Measured through 5 years after study enrollment)
- Overall survival (OS)(Measured through 5 years after study enrollment)
- pCR in the Breast and Nodes(Time of surgery)
- Neo-bioscore(Time of surgery)
- Near pCR in the Breast(Time of surgery)
- Distant-disease- free survival (DDFS)(Measured through 5 years after study enrollment)
- Clinical and imaging response(Time of surgery)