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 ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-005017-36

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

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Extrait

The primary objective of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer (stage III b/IV) which has progressed during or after endocrine therapy. HER-2/neu 2+ patients must have a negative FISH test.


Critère d'inclusion

  • Hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV), which are known to express HER-2/neu (1+ or 2+) and are FISH negative