NCT00431704进行中（未招募）2 期
Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
National Cancer Institute, Naples1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2007年10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
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- side effects
研究概览
简要总结
The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.
详细描述
The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of breast cancer
- •Stage IV disease
- •None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
- •Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
- •ECOG Performance Status 0-2
- •Age >18 and < 75 years
- •Left Ventricular Ejection Fraction (LVEF) >50%
- •Life expectancy >3 months
- •Signed informed consent
排除标准
- •Absence of measurable or evaluable disease
- •Life expectancy < 3 months
- •ECOG performance status > 2
- •History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
- •Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
- •Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
- •Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl
- •Creatinine > 1.5 x the upper normal limits
- •GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases
- •GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases
- •Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
- •Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- •Male gender
- •Pregnant or lactating women
- •Refusal or incapacity to provide informed consent
- •Inability to comply with follow up
研究组 & 干预措施
vinorelbine, carboplatin, trastuzumab
Experimental
干预措施: vinorelbine (Drug)
vinorelbine, carboplatin, trastuzumab
Experimental
干预措施: carboplatin (Drug)
vinorelbine, carboplatin, trastuzumab
Experimental
干预措施: trastuzumab (Drug)
结局指标
主要结局
side effects
时间窗: after every cycle of therapy
objective response rate
时间窗: after 3 and 6 cycles of therapy
次要结局
- time to progression(at 12 months, end of study)
- overall survival(at 12 months, end of study)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab for HER2 Positive Patients Following Neoadjuvant ChemotherapyBreast CancerNCT04302441Fudan University550
招募中
2 期
Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in ChinaBrain MetastasesBreast CancerNCT04334330Sun Yat-sen University34
已完成
1 期
A Phase I/II Study of Vinorelbine plus Trastuzumab in Patients with Advanced/Recurrent Breast Cancer Previously Treated with Anthracyclines and TaxanesBreast cancerJPRN-C000000447Kyushu Breast Cancer Study Group60
已完成
2 期
Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast CancerBreast NeoplasmNCT00194727University of Washington40
已完成
3 期
Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC)Non-small Cell Lung CancerNCT01124253Shanghai Jiao Tong University School of Medicine250