phase II study of the trifunctional anti-her-2/neu x anti-cd3 antibodyertumaxomab for hormone therapy refractory patients with her-2/neu 1 or 2 expressing advanced or metastatic breast cancer - ND
- Conditions
- female patients with advanced or metastatic breast cancer stage IIIb or IVMedDRA version: 6.1Level: PTClassification code 10006187
- Registration Number
- EUCTR2005-004294-21-IT
- Lead Sponsor
- FRESENIUS BIOTECH GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 40
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 Aged 18 years and older. c Histologically or cytologically confirmed invasive breast cancer with stage IIIb or IV disease with documented progression. d Measurable disease according to RECIST. e 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. f Hormone receptor status ERs positive and/or PRs positive. g No prior treatment with mouse or rat antibodies. h Life expectancy of at least six months if the life expectancy of a patient is unspecified she will be allowed to enter the study . i An Eastern Cooperative Oncology Group ECOG performance score of 1. j Patients must have had disease progression after hormonal therapy including at least one aromatase inhibitor. k 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
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 109/l Hemoglobin Hb 10 g/dl Neutrophil count 1500/mm3 1.5 x 109/l White blood cells WBC 3 x 109/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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to demonstrate clinical efficacy of the investigational trifunctional antibody ertumaxomab for the treatment of hormone therapy refractory advanced or metastatic breast cancer stage IIIb or IV tumors that are known to express HER-2/neu 1 or 2 .;Secondary Objective: The secondary objectives of this study are Time to progression TTP . Duration of response. Time to response. Clinical benefit of ertumaxomab defined as confirmed CR, PR and stable disease SD . Response of tumor markers carbohydrate antigen 15-3 CA15-3 and carcinoembryonic antigen CEA to treatment with ertumaxomab.;Primary end point(s): The primary endpoint is objective response rate ORR to ertumaxomab, defined as the proportion of patients with a confirmed complete response CR or partial response PR according to Response Evaluation Criteria in Solid Tumors RECIST Appendix 5 at two months day 70 5 days after treatment, using the evaluable population.
- Secondary Outcome Measures
Name Time Method