NCT00842998Unknown2 期
A Phase II, Randomized Trial With Single Agent Trastuzumab or Lapatinib in Patients With Metastatic HER2-Overexpressing Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Evidence of clinically definite response confirmed by CT or MRI
研究概览
简要总结
This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A companion biological study will assess factors correlated with sensitivity or resistance to either one of the compounds
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-75 years
- •Histologically or cytologically confirmed metastatic disease.
- •HER2-Overexpression proven by Fluorescence in Situ Hybridization (FISH).
- •Availability of paraffin-embedded block of either primitive tumor and/or biopsy of metastases.
- •No prior chemotherapy for metastatic or locally advanced disease. Patients with hormone receptor (oestrogen and/or progesterone) positive breast cancer can be eligible provided that they had received only ONE line of hormonal therapy for metastatic disease.
- •For patients undergoing hormonal therapy for metastatic disease, disease progression must be confirmed according to RECIST criteria.
- •At least 20% increase in the sum of longest diameters, OR
- •Evidence of new metastatic lesions or progression of pre-existing non-target lesions.
- •Presence of at least one monodimensionally measurable lesion. Patients without clinically or radiologically proven evidence of disease are not eligible.
- •Patients with exclusively skin disease are eligible, provided that the disease evolution under treatment can be photographically documented.
- •Patients with involvement of NCS, besides presence of measurable lesions, are eligible provided that:
- •Brain lesion/s has/have been radically resected;
- •Brain lesion/s has/have obtained complete remission following radiation therapy. Complete remission must be documented by TC or RMN.
- •At least 4-week interval from end of radiotherapy, hormono- or immunotherapy and enrollment in this study.
- •ECOG PS </= 2 and life expectancy of at least 6 months.
- •Liver metastases involving < 30% of liver volume.
- •Adequate hematopoietic, liver and renal function
- •Written informed consent.
- •Patients with childbearing potential must have negative pregnancy test and must use adequate contraceptive measures during treatment.
- •Prior treatment with Trastuzumab as adjuvant therapy is permitted provided that it was completed at least 12 months prior enrollment in this study.
排除标准
- •Prior chemotherapy for metastatic disease.
- •Active pregnancy or breastfeeding.
- •Previous treatment with Lapatinib.
- •Previous therapy with mono- or policlonal antibodies for metastatic disease.
- •Patients with bone involvement or pleural effusion/ascites as unique localization of disease.
- •Patients with dyspnea due to presence of disease (lymphangitis) or requiring oxygen therapy.
- •Patients with clinically evident hearth disease and/or active infectious diseases.
- •Patients with not resected or not irradiated brain and/or leptomeningeal metastases.
- •Prior or actual concurrent neoplasms, with the exception of adequately treated carcinoma della cervice uterina and basal cell or squamocellular carcinoma of the skin.
- •Patients with uncontrolled serious illnesses that may compromise the compliance of the patient to the treatment.
- •Previous allergic reactions towards any excipient in the composition of Trastuzumab or Lapatinib.
- •Use of any experimental drug within 4 weeks prior initiation of study treatment.
- •Women with childbearing potential who refuse to use adequate contraceptive measures.
- •Patients unable to give written informed consent or are not compliant with treatment.
- •Patients with great tumor involvement (> 30% dof hepatic volume, etc).
研究组 & 干预措施
1 - Trastuzumab
Experimental
Day1 Week1: 8 mg/kg iv in 90 min. Following 1st week: 2 mg/kg once/weekly for 8 weeks
干预措施: Trastuzumab or Lapatinib (Drug)
2 - Lapatinib
Experimental
1500 mg/die orally
干预措施: Trastuzumab or Lapatinib (Drug)
结局指标
主要结局
Evidence of clinically definite response confirmed by CT or MRI
时间窗: 8 weeks
次要结局
- Time to Progression (TTP) and duration of response in patients treated with Trastuzumab(8 weeks)
研究者
研究点 (4)
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