A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanc...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-008276-14

A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancer who have progressed while receiving prior therapy

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Extrait

• To characterize the safety and tolerability of the combination of T-DM1 and pertuzumab administered every 3 weeks to patients with HER2-positive locally advanced or metastatic breast cancer who have previously received trastuzumab in any line of therapy, have received chemotherapy combined with HER2-targeted therapy for advanced disease, and have progressed while receiving their most recent therapy • To evaluate the pharmacokinetics of T-DM1 when the combination of T-DM1 and pertuzumab is administered on this schedule • To make a preliminary assessment of the efficacy of the combination of T-DM1 and pertuzumab administered on this schedule, as measured by objective response rate based on investigator assessment using modified RECIST, Version 1.0


Critère d'inclusion

  • Treatment in patients with HER2-overexpressing locally advanced or metastatic breast cancer