EUCTR2006-005017-36-ES进行中（未招募）不适用
Phase II study for repeated dosing of the trifunctional bispecific anti-HER-2/neu x anti-CD3 antibody ertumaxomab in patients with HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastatic breast cancer (stage IIIb/IV) progressing after endocrine treatmentEstudio de fase II de la administración repetida del anticuerpoanti-HER-2/neu x anti-CD3 trifuncional biespecífico ertumaxomab enpacientes con cáncer de mama avanzado o metastásico (estadio IIIb/IV) conexpresión de HER-2/neu 1+ o 2+/negativo en FISH que progresan después detratamiento hormonal
Fresenius Biotech GmbH0 个研究点目标入组 40 人开始时间: 2007年3月5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
- •1. Signed and dated informed consent form
- •2. Female gender, aged >= 18 years and with a life expectancy of at least 6 months
- •3. Negative pregnancy test at screening (and not more than 72 hours prior to the first ertumaxomab infusion) for women of childbearing potential and patients must agree to use adequate contraception during the study
- •4. Histologic diagnosis of adenocarcinoma originating in the breast
- •5. Evidence that the cancer is locally advanced (stage IIIb) or metastatic (stage IV) and not curable by local measures i.e., surgery, radiation
- •6. Measurable disease, defined as at least one lesion that is measurable in one dimension (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
- •7. HER-2/neu expression 1+ or 2+ (confirmed by Dako HercepTest®). HER-2/neu 2+ patients must have a negative FISH test
- •8. Hormone receptor status Estrogen Receptors (ERs) positive and/or Progesterone Receptors (PRs) positive
- •9. Prior adequate endocrine therapy for advanced or metastatic disease.
- •10. Disease progression during or after endocrine therapy
- •11. No prior treatment with mouse or rat antibodies
- •12. Eastern Cooperative Oncology Group (ECOG) performance score of = 1
- •13. Adequate hematological, liver and kidney function: Thrombocytes >= 100000/mm³ (= 100 x 10E9/L). Neutrophil count >= 1500/mm³ (= 1.5 x 10E9/L). Serum glutamic oxaloacetic transaminase (SGOT/aspartate aminotransferase [AST]) and serum glutamic pyruvate transaminase [SGPT]/alanine aminotransferase [ALT]) within limits of normal; in patients with liver metastases <= 2.5 x upper limit of normal (ULN). Serum bilirubin within normal limits; in patients with liver metastases serum bilirubin <= 1.5 x ULN. Creatinine <= 1.5 x ULN or clearance = 60 mL/min. Partial thromboplastin time (PTT) within limits of normal
- •14. Adequate recovery from prior systemic therapy
- •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
- •1. Women who are pregnant or breast-feeding
- •2. Known Human Immunodeficiency Virus (HIV) infection
- •3. Unable or unwilling to comply fully with the protocol
- •4. Any history or symptoms indicative of brain or central nervous system metastases
- •5. Patients with a prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- •6. Presence of autoimmune disease
- •7. Documented acute or chronic infection requiring antibiotic treatment
- •8. Concurrent non-malignant co-morbidities that are uncontrolled
- •9. Any concurrent chemotherapy, hormonal therapy, immunotherapy or corticoid therapy
- •10. Any concurrent investigational treatment for advanced or metastatic disease
- •11. History of relevant cardiovascular disease as follows: Left ventricular ejection fraction (LVEF) below the institution’s lower limit of normal, based on echocardiography (ECG) at rest. Uncontrolled or symptomatic congestive heart failure (New York Heart Association (NYHA) >= 2. Uncontrolled or symptomatic arrhythmia. Uncontrolled angina pectoris. Myocardial infarction during the last 2 years
研究者
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