NCT03703427尚未招募2 期
Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID
Zhiyong Yu1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- disease free survival(DFS)
研究概览
简要总结
This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis.
- •Stage I-IIIB at the first diagnosis and underwent curative resection.
- •The patient was non-pCR after preoperative chemotherapy including anthracycline agents and paclitaxel or docetaxel; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells.The previously adminstered preoperative chemotherapy must have involved 8 cycles of EC-T or 6 cycles of TEC.If HER-2 is positive, trastuzumab is applied with T chemotherapy
- •The patient has high risk: young;triple negtive breast caner; positive axillary lymphnode;HER-2 positive;ect
- •The patient's general performance status is 0 to
- •The patient must have no carry-over of efficacy from any previous treatment.
- •The patient has maintained sufficient organ function to permit valid evaluation.
- •The patient must have no adverse drug reactions of grade 2 or higher carried over from previous treatment.
- •The patient's creatinine clearance is higher than 50 ml/min
- •The patient has personally given written, informed consent to participate in this study.
排除标准
- •The patient is considered to require postoperative chemotherapy other than capecitabine and vinorelbine.
- •The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).
- •The patient has either simultaneous or non-simultaneous bilateral breast cancer.
- •The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible.
- •The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.
- •The patient has previously had an organ transplant.
- •The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane.
- •The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months.
- •The patient has a fever, and there is the possibility that she has an infection.
- •The patient has been shown to have metastasis to other organs.
- •The patient requires treatment for epilepsy and/or central nervous system disorders.
- •The patient is currently being treated for, or has a history of, psychiatric disease.
- •It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome.
- •For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.
研究组 & 干预措施
Capecitabine
Experimental
干预措施: Capecitabine, Oral, 500 Mg (Drug)
Vinorelbine
Experimental
干预措施: Vinorelbine Tartrate Oral (Drug)
结局指标
主要结局
disease free survival(DFS)
时间窗: 5 years
To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.
次要结局
- overall survival(OS)(5 years)
- medicine safety(5 years)
研究者
Zhiyong Yu
Director of the Breast Surgery Ⅰ
Shandong Cancer Hospital and Institute
研究点 (1)
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