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Multicenter Clinical Trial in subjects with HER2-negative primary tumors. The subjects will be evaluated for the presence of HER2 positive Circulating Tumor Cells (CTCs) in blood. In case of at leas...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-005352-41

Multicenter Clinical Trial in subjects with HER2-negative primary tumors. The subjects will be evaluated for the presence of HER2 positive Circulating Tumor Cells (CTCs) in blood. In case of at least one HER2-positive CTC in blood, the subject will be randomized to receive either (nabTM)-paclitaxel + trastuzumab (ARM A) or (nabTM)-paclitaxel (ARM B). Studio multicentrico in pazienti con tumori primari HER2 negativi. I pazienti saranno valutati per la presenza di cellule tumorali circolanti (CTC) HER2 positive nel sangue. In caso di positività di HER2 su almeno una CTC, il paziente sarà randomizzato per il trattamento con (nabTM)-paclitaxel + trastuzumab (BRACCIO A) oppure con (nabTM)-paclitaxel (BRACCIO B)

Femme Homme

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Extrait

To determine the overall Clinical Benefit (CB) of the two regimens (nab-paclitaxel plus trastuzumab (ARM A) versus nab-paclitaxel alone (ARM B)) among evaluable patients. Determinare il beneficio clinico complessivo (CB) dei due regimi nab-paclitaxel più trastuzumab (braccio A) rispetto al nab-paclitaxel (braccio B) da solo tra i pazienti valutabili.

Critère d'inclusion

  • Metastatic Breast Cancer in HER2- positive CTC with primary HER2-negative,Tumore mammario metastatico con CTC HER2-positive e tumore primario al seno HER2-negativo

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