EUCTR2005-004294-21-BE进行中（未招募）不适用
Phase II study of the trifunctional anti-HER-2/neu x anti-CD3 antibody ertumaxomab for hormone therapy refractory patients with HER-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer
Fresenius Biotech GmbH0 个研究点目标入组 40 人开始时间: 2005年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •a) Female gender, and if of child-bearing potential must have a negative pregnancy test result within 2 days before enrolment and must agree to practice effective birth control during the study.
- •b) Histologically or cytologically confirmed invasive breast cancer with stage IIIb or IV disease with documented progression.
- •c) Measurable disease according to RECIST.
- •d) Histologically documented advanced primary breast cancer or biopsy of metastatic site demonstrating HER-2/neu expression (HER-2/neu 1+ or 2+ determined by immunohistochemistry (IHC)). HER-2/neu 2+ patients must have a negative FISH test. If an IHC test other than the Dako HercepTest® has been performed, then a confirmatory Dako HercepTest® has to be performed at the central laboratory. The results of the IHC tests other than the Dako HercepTest® can be accepted for inclusion, but the results from these tests have to be confirmed by the Dako HercepTest® afterwards.
- •e) Hormone receptor status ERs positive and/or PRs positive.
- •f) No prior treatment with mouse or rat antibodies.
- •g) Life expectancy of at least six months (if the life expectancy of a patient is unspecified she will be allowed to enter the study).
- •h) An Eastern Cooperative Oncology Group (ECOG) performance score of i) Patients must have had disease progression after hormonal therapy including at least one aromatase inhibitor.
- •j) Adequate hematological, liver and kidney function (refer to exclusion criterion i).
- •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
- •a) Pregnant or lactating women.
- •b) Life-threatening visceral disease.
- •c) Known brain or central nervous system metastases.
- •d) Symptomatic pleural effusions.
- •e) Symptomatic pericardial effusions.
- •f) History of relevant cardiovascular disease:
- •· Left ventricular ejection fraction (LVEF) below normal institutional ranges as measured by echocardiogram or MUGA scan
- •· Uncontrolled or symptomatic congestive heart failure (New York Heart Association [NYHA] Classification >/= 2)
- •· Myocardial infarction within the past two years
- •· Uncontrolled or symptomatic cardiac arrhythmias
- •g) Severe dyspnea.
- •h) Pulmonary dysfunction or require continuous supportive oxygen inhalation.
- •i) Symptoms or signs (including laboratory tests) of relevant concomitant hematological, hepatic, renal disease, in particular:
- •· Thrombocytes < 100 x 10E9/l
- •· Hemoglobin (Hb) < 10 g/dl
- •· Neutrophil count < 1500/mm3 ( = 1.5 x 10E9/l)
- •· White blood cells (WBC) < 3 x 10E9/l
- •· Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) > 2.5 x upper limit of normal (ULN)
- •· Serum bilirubin > 2 x ULN
- •· Creatinine > 1.5 x ULN or clearance < 60 ml/min
- •j) Patients whose only site of metastatic involvement is bone metastases. With the exception of those with a measurable soft tissue component of the bone lesion seen with imaging that does not require palliative radiation intervention and/or the patient has a lytic bone lesion >/= 1 cm measured with radiography that can be followed for evidence of re-calcification.
- •k) Other concurrent uncontrolled co-morbid illness.
- •l) Other concurrent malignancy, except treated basal cell or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix.
- •m) Patients with documented autoimmune diseases (such as lupus) are excluded from participation in the study unless a waiver is granted by the responsible medical monitor.
- •n) Human immunodeficiency virus, hepatitis B or hepatitis C positive status.
- •o) Any prior or concurrent chemotherapy regimen for advanced or metastatic disease.
- •p) Prior neo-adjuvant or adjuvant chemotherapy was stopped less than six months before study entry.
- •q) Any concurrent hormone therapy. Hormone therapy must be stopped at latest at the screening visit.
- •r) Radiotherapy within 4 weeks before study entry.
- •s) Any concurrent immune therapy.
- •t) Any concurrent corticosteroid therapy.
- •u) Any prior investigational therapy for advanced or metastatic disease.
- •v) Any regularly used medication for a health condition or comorbidity that might result in undue risk to the patient.
- •w) Unable or unwilling to comply fully with the protocol.
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