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Randomized Phase II study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects with Her2+ Locally Advanced and/or Metastatic Breast Cancer. Estudio fase II de Ixabepilon...

Update Il y a 5 ans
Reference: EUCTR2007-000721-21

Randomized Phase II study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects with Her2+ Locally Advanced and/or Metastatic Breast Cancer. Estudio fase II de Ixabepilona y Trastuzumab versus Docetaxel y Trastuzumab en mujeres con cáncer de mama localmente avanzado y/o mestatásico con sobresexpresión de Her2

Woman Man

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Extract

To estimate the response rate for ixabepilone plus trastuzumab and the response rate for docetaxel plus trastuzumab in female subjects with Her2+ locally advanced and/or metastatic breast cancer not previously treated with chemotherapy or trastuzumab in the metastatic setting. Response is defined as partial response (PR) or complete response (CR) according to RECIST criteria (see Protocol Sections 6.4.1.3 and 8.3.1).

Inclusion criteria

  • Female Subjects with Her2+ Locally Advanced and/or Metastatic Breast Cancer,Mujeres con cáncer de mama localmente avanzado y/o mestatásico con sobreexpresión de Her2

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