EUCTR2006-000703-42-IT进行中（未招募）不适用
A phase III randomized trial of trastuzumab continuation vs discontinuation in combination with 2nd-line chemotherapy after progression on a 1st-line trastuzumab-chemotherapy combination for HER2 overexpressing metastatic breast cancer patients. - THOR
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients must show their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •Documented diagnosis of metastatic breast carcinoma (stage IV) HER2 overexpressing (ICH 3+ or FISH +).
- •Progressive disease after 1st line Herceptin+chemotherapy combination (previous hormonal therapies without trastuzumab for metastatic disease are allowed).
- •Patients must have received as 1st line chemotherapy no other drugs than taxanes, vinorelbine, capecitabine, gemcitabine, platinum compounds, fluorouracil, cyclophosphamide, methotrexate always in association with Herceptin
- •Female gender.
- •ECOG performance status 0-1 (see Appendix 1).
- •Life expectancy > 3 months.
- •Neutrophils > 1.5x109/L and platelets > 100x109/L.
- •Total bilirubin < 1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT and/or ALAT < 2.5 UNL, alkaline phosphatase < 5 UNL (unless bone metastasis are present in the absence of any liver disorders). Creatinine < 1.5 UNL
- •At least one measurable leasion according to Recist criteria (max diameter > 2 cm if conventionally measure or > 1 cm if assessed by spiral TC, see Appendix 2)
- •Complete work-up within 3 weeks prior to registration, including total body CT scan (torax,abdomen, pelvis) or MRI, cardiologic evaluation by echocardiogram or MUGA scan and ECG and complete hematological and biological work-up
- •LVEF > 50% as determined by echocardiogram or MUGA scan
- •Women of child bearing potential must have a negative serum pregnancy test and be using adequate contraception (prescribed under medical supervision). Examples of adequate contraceptive measures are intra-uterine device, barrier method (condoms, diaphragm), also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not indicated in this patient population!
- •Patients must be accessible for treatment and follow-up.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •No hormonal and antracyclines regimens are allowed, except pegylated liposomal doxorubicin (pegylated and not) as previous 1st line chemotherapy associated to Herceptin Serious illness or medical condition: - Congestive hearth failure or angina pectoris even if it is medically controlled. - Previous history of myocardial infarction, uncontrolled high-risk ipertension or arrhythmia. - History of significant neurological or psychiatric disorders including dementia or seizures. - Active infection, active peptic ulcer, unstable diabetes mellitus or contraindications for the use of steroids. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening. Occurrence of cardiac toxicity during 1st line Herceptin+chemotherapy treatment defined as follows: - a fall from baseline resting LVEF of 20% or more EF units (LVEF should be reassessed within one week to confirm the diagnosis) - signs and symptoms of CHF classified as grade III or more according to NYHA classification (see Appendix 3). Patients with symptomatic brain metastases. Patients with bone as just one site of metastases. Patients with brain as just one progression site to the 1st line trastuzumab-chemotherapy combination. Patients not receiving suggested regimens as 2nd line chemotherapy (see table 6 for a list of suggested chemotherapy regimens.
研究者
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