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 treatment - ND

FRESENIUS BIOTECH GMBH0 个研究点目标入组 40 人开始时间: 2007年6月15日最近更新: 2012年3月19日

试验速览

暂无简介。

•a.Female gender, aged 18 or older, with life expectancy of at least 6 months; b.Negative pregnancy test at screening (and not more than 72 hours prior to the first ertumaxomab infusion).For women of childbearing potential, patients must agree to use adequate contraception during the study; c.Histologic diagnosis of adenocarcinoma originating in the breast; d.Evidence that the cancer is locally advanced (stage IIIb) or metastatic (stage IV) and not curable by local measures i.e. surgery, radiation; e. Measurable disease, defined as at least one lesion that is measurable in one dimension (Response Evaluation Criteria in Solid Tumors [RECIST criteria]); f. HER-2/neu expression 1+ or 2+ (confirmed by Dako Hercep Test). HER-2/neu 2+ patients must have a negative FISH test; g. Hormone Receptors (ERs) positive and /or Progesterone Receptors (PRs) positive; h. Prior adequate endocrine therapy for advanced or metastatic disease; i. Disease progression during or after endocrine therapy; l. No prior treatment with mouse or rat antibodies;m. Adeguate hematological, liver, kidney function; n. Creatinine < 1.5 x ULN or clearance > 60 mL/min; o. 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) no
•F.1.3.1 Number of subjects for this age range

•a. Women who are pregnant or breast feeding; b. Known Human Immunodeficiency Virus (HIV) Infection; c. Any history or symptoms indicative of brain or central nervous system metastases; d. Presence of Autoimmune diseases; e. Any concurrent chemotherapy, hormonal therapy, immunotherapy or corticoid therapy; f. Any concurrent investigational treatment for advanced or metastatic disease; g. 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 arythmia - Uncontrolled angina pectoris - Myocardial infarction during the last 2 years.

发起方

FRESENIUS BIOTECH GMBH