Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- clinical/pathological response
研究概览
简要总结
This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further enhance the cytotoxic activity in breast cancer.
详细描述
This is an open labelled, prospective, randomized, phase II clinical trial. A total of 60 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with neoadjuvant systemic therapy are eligible for entry into this study. Patients will be allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar or 3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound (CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET) scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary endpoint is clinical/pathological response. The secondary endpoint is (1) the safety and tolerability of the regimens, (2) the role of mammography, CEUS, MRA and PET for response evaluation, and (3) angiogenic profile and biological information involved in tumor response.
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
- Single (Participant)
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
- •Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
- •Stage ⅡA-ⅢC
- •Age 18-70
- •ECOG performance status 0-2
- •No evidence of distant metastasis
- •No previous therapy
- •Normal hematologic function
- •left ventricular ejection fraction greater than 50 percent
- •No abnormality of renal or liver function
- •Written informed consent
排除标准
- •With allergic constitution or possible allergic reflection to drugs to be used in this study
- •Any concurrent uncontrolled medical or psychiatric disorder
- •History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease.
- •History of bleeding diathesis
- •Being pregnant or nursing
研究组 & 干预措施
chemotherapy
neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin
干预措施: docetaxel and epirubicin (Drug)
chemotherapy plus endostatin
neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin
干预措施: docetaxel and epirubicin plus endostatin (Drug)
结局指标
主要结局
clinical/pathological response
时间窗: one year
次要结局
- safety and tolerability(one year)