JPRN-UMIN000018722招募中2 期
Phase II randomized clinical trial evaluating neoadjuvant chemotherapy regimens with tri-weekly docetaxel (D) followed by doxorubicin, 5-fluorouracil, and cyclophosphamide (FEC) or docetaxel with concurrent use of capecitabine (TX) followed by doxorubicin, cyclophosphamide, and capecitabine (CEX) in women with locally advanced triple-negative breast cancer - Phase II trial to evaluate the feasibility of neoadjuvant chemotherapy with docetaxel with concurrent use of capecitabine (TX) followed by doxorubicin, cyclophosphamide, and capecitabine (CEX) for triple-negative breast cancer
Japanese Red Cross Society Himeji Hospital0 个研究点目标入组 84 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Cancer-Related Exclusion Criteria 1. History of anticancer therapy for breast cancer. This includes any EGFR or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen for breast cancer. 2. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma, thyroid cancer, early stage stomach, or colon cancer. 3. Current uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg) or unstable angina 4. History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia). History of myocardial infarction within 6 months of randomization. 5. Current dyspnea at rest due to complications of interstitial pneumonia, or other diseases that require continuous oxygen therapy General Exclusion Criteria 6. Inadequate organ function, evidenced by the following laboratory results within 28 days prior to randomization: Absolute neutrophil count < 1,500 cells/mm3 Platelet count < 100,000 cells/mm3 Hemoglobin < 9 g/dL Total bilirubin > upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) > 2.5 x ULN Serum creatinine > 2.0 mg/dL 7. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures) 8. Pregnant or lactating women 9. History of receiving any investigational treatment within 28 days of randomization 10. Receipt of intra-venous antibiotics for infection within 14 days of randomization 11. Current chronic daily treatment with corticosteroids (dose of > 10 mg per day methylprednisolone equivalent) 12. Known hypersensitivity to any of the study drugs 13. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
研究者
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