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
An open-label, non-randomized, uncontrolled, one-stage, phase II study evaluating the
efficacy and safety of the investigational trifunctional bispecific antibody ertumaxomab
(anti-Her-2/neu x anti-CD3) for the treatment of hormone therapy refractory advanced or
metastatic breast cancer tumours (stage IIIb or IV) which are known to express HER-2/neu (1+
or 2+/FISH negative).Ertumaxomab will be administered at 7 day intervals by constant rate 3
hour intravenous (i.v.) infusions according to the following sequential dose schedule: 10 µg
(day 0) and thereafter 100 µg flat doses once every 7 days (± 1 day) for a maximum of up to
12 weeks or until disease progression or any other unacceptable toxicity.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical efficacy measured by objective response rate (best response during the course of the study)
José Baselga / Javier Cortes
Principal Investigator
Hospital Vall d'Hebron, Barcelona, Spain
Austria: Agency for Health and Food Safety
IV-ERT-BC-03
NCT00452140
March 2007
February 2009
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