A randomized, multicenter, Phase II study of the efficacy and safety of trastuzumab-MCC-DM1 vs. trastuzumab (Herceptin®) and docetaxel (Taxotere®) in patients with metastatic HER2-positive breast canc...

Update Il y a 4 ans
Reference: EUCTR2008-002819-40

A randomized, multicenter, Phase II study of the efficacy and safety of trastuzumab-MCC-DM1 vs. trastuzumab (Herceptin®) and docetaxel (Taxotere®) in patients with metastatic HER2-positive breast cancer who have not received prior chemotherapy for metastatic disease

Woman and Man

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Extract

The primary objectives for this study are as follows: • To explore the efficacy of T-DM1 compared with the combination of trastuzumab and docetaxel in patients with HER2-positive, unresectable, locally advanced breat cancer and/or metastatic breat cancer who have not received prior chemotherapy for metastatic disease, as measured by PFS based on investigator assessments • To evaluate the safety of T-DM1 compared with the combination of trastuzumab and docetaxel in this population


Inclusion criteria

  • HER2 positive metastatic breast cancer