Hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express HER-2/neu (1+ or 2+)
Conditions
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 2.5 x upper limit of normal (ULN) · Serum bilirubin > 2 x ULN · Creatinine > 1.5 x ULN or clearance /= 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate clinical efficacy of the investigational trifunctional antibody (ertumaxomab) for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express HER-2/neu (1+ or 2+). ;Secondary Objective: To determine further efficacy data in terms of time to progression (TTP), duration of response, clinical benefit, tumor markers and safety data.;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) at two months (day 70 ±5 days) after treatment using the evaluable population | — |
Countries
Austria, Belgium, Italy, Spain
Outcome results
None listed