NCT00795899已完成2 期
Preoperative Therapy With Epirubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab and Postoperative Therapy With Trastuzumab in Patients With HER-2 Over Expressed Breast Cancer
German Breast Group1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2002年1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
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy.
研究概览
简要总结
The present clinical trial will investigate the safety and efficacy of a sequential preoperative therapy with Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression primary breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary carcinoma of the breast, confirmed histologically by core biopsy (at least 3 core biopsy samples)
- •Tumor lesion of the breast with a palpable or a imagistic size ≥ 2 cm or inflammatory breast cancer
- •Known HER-2 status detected on core biopsy. HER-2 over expression is defined as DAKO HercepTest (3+) or DAKO HercepTest (2+) and FISH (+) (fluorescence-in-situ-hybridisation).
- •No distant metastatic disease, confirmed by chest x-ray, abdominal sonography and bone scan.
- •Female patients
- •Age ≥ 18 and ≤ 65 years
- •ECOG < 2/WHO 0-1
- •Laboratory requirements GOT and Bilirubin < 1.5x UNL Leukocytes >= 3 G/l Neutrophile > 1 G/l Thrombocytes > 100 G/l Creatinine (Serum) < 2.0 mg/dl.
- •Normal cardiac function, confirmed by cardiologist
- •No active hepatitis
- •Written informed consent for all study procedures
- •Patients must be available and compliant for treatment and follow-up
排除标准
- •Multicentricity in various quadrants (contact the study office)
- •CNS-metastases
- •Secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the cervix that has received curative therapy
- •Patients with relevant hemodynamic cardial diseases
- •Patients with a left ventricular ejection fraction (LVEF) under the normal limit of the institution, confirmed by echocardiography or MUGA-Scan.
- •Uncontrolled, severe comorbidities
- •Patients with severe respiratory diseases and severe dyspnea and / or which need supportive oxygen
- •Previous anti-HER2-therapy
- •Patients receiving immunosuppressant therapy
- •Known allergy to medication containing cremophor
- •Hb <10 g/dL, Neutrophile <1.5 x109/L, Thrombocytes <100 x109/L.
- •Total-Serum-Bilirubin >1.5 x ULN (upper limit of normal) (except in patients with confirmed and documented Gilbert-Lereboullet-syndrome), ALT or AST >2.5 x ULN (>5 x ULN by liver metastases), Alkaline Phosphatase >2.5 x ULN (>4 x ULN by liver or bone metastases), Serumcreatinine > 2 x ULN
- •Pregnancy, nursing (a negative pregnancy test must be documented, and safe anticontraceptive measures during pre- and postoperative treatment must be implemented)
- •Lack of signed informed consent after informing the patient
- •Lack of willingness to keep and disclose personal medical data as part of the study
研究组 & 干预措施
1
Experimental
Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression
干预措施: Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab (Drug)
结局指标
主要结局
To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy.
时间窗: 36 months
次要结局
- To evaluate the quality of life.(36 months)
- To assess: the rate of breast conserving surgery, the clinical response rates, the histopathological lymph node status after preoperative therapy, the disease-free and overall survival.(36 months)
研究者
研究点 (1)
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