NCT04194684Unknown2 期
Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer：a Multi-center Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 108
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 to 70 years old;
- •histologically confirmed recurrent or metastatic breast cancer, ER-positive (> 10%), HER-2 negative (Definition: immunohistochemical [IHC] 0, 1+, or in situ hybridization [ISH] negative It is defined as the ratio of HER2 gene copy number to the number of CEP17 signals is less than 2.0, or for single probe detection, the HER2 gene copy number is less than 6);
- •After transfer, ≤2 lines and ≥1 line endocrine therapy, and progress;
- •at least one measurable lesion according to RECIST 1.1 ;
- •ECOG score≤2;
- •Expected survival≥3 months;
- •Bone marrow function: white blood cells≥3×109/L, neutrophils≥1.5×109/L, platelets ≥100×109 / L, hemoglobin≥90g / L;
- •Liver and kidney function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (Cr) ≤1.5 times the upper limit of normal value;
- •taxane adjuvant chemotherapy for more than 1 year;
- •Women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose
- •Sign written informed consent before the test.
排除标准
- •Received chemotherapy after transfer;
- •Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;
- •Uncontrolled brain metastases;
- •Severe systemic infections;
- •Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;
- •Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;
- •History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
- •Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;
- •Patients participating in other clinical trials at the same time;
- •Any medical condition in which the investigator considers the patient unsuitable for study
研究组 & 干预措施
Assigned Interventions
Experimental
Nab-paclitaxel
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Estimated up to 1 year
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
次要结局
- Clinical benefit rate(CR+PR+SD≥8 weeks)
- Progression-Free Survival (PFS)(Estimated up to 2 year)
研究者
Peng Yuan
Professor
Chinese Academy of Medical Sciences
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