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A multicenter, multinational phase II study to assess the clinical safety and feasibility of T-DM1 sequentially with anthracyline-based chemotherapy, as adjuvant or neoadjuvant therapy for patients wi...

Update Il y a 5 ans
Reference: EUCTR2010-019752-50

A multicenter, multinational phase II study to assess the clinical safety and feasibility of T-DM1 sequentially with anthracyline-based chemotherapy, as adjuvant or neoadjuvant therapy for patients with early stage HER2-positive breast cancer

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Extract

To assess the clinical safety and feasibility of T-DM1 after the completion of doxorubicin/cyclophosphamide (AC) or 5-fluorouracil (5-FU)/epirubicin/ cyclophosphamide (FEC) adjuvant/neoadjuvant chemotherapy regimen in HER-2/neu overexpressed/amplified early breast cancer (EBC) patients: • To evaluate the rate of cardiac events during T-DM1 treatment when initiated after completion of anthracycline-containing chemotherapy • To evaluate the safety profile of T-DM1

Inclusion criteria

  • Treatment of HER2 positive adjuvant or neoadjuvant therapy

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