Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Tr...

Update Il y a 4 ans
Reference: EUCTR2008-000709-12

Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naïve Patients With HER2-Positive Breast Cancer

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Extract

To compare the efficacy of up to 8 cycles (24 weeks) of MYOCET plus cyclophosphamide and trastuzumab for 4 cycles followed by docetaxel plus trastuzumab for 4 cycles (MCH→TH) with free doxorubicin plus cyclophosphamide alone for 4 cycles followed by docetaxel plus trastuzumab for 4 cycles (AC→TH), each on day 1 of a 21-day cycle, as assessed by the proportion of patients with pathological complete response (pCR).


Inclusion criteria

  • Patients with human epidermal growth factor receptor-2 (HER2) positive stage II or III breast cancer