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A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women with Early Stage Breast Cancer Revised Protocol 0...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003047-24

A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women with Early Stage Breast Cancer Revised Protocol 02 incorporating Protocol Amendments 02 (version 1.0, dated 25-May-07) and 03 (version 1.0, dated 22-May-08) + Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 1.0, dated 21-Dec-2006)

Femme Homme

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Extrait

• To estimate the pCR rate of AC followed by ixabepilone relative to the pCR rate for AC followed by paclitaxel in women with early stage breast cancer. • To estimate the pCR rate of AC followed by ixabepilone relative to the pCR rate for AC followed by paclitaxel in a biomarker-defined population based on the following pre-defined biomarker sets: − β3 tubulin assessed by immunohistochemistry (IHC), − CAPG assessed by mRNA, − TACC3 assessed by mRNA, − A set of 20 genes assessed by mRNA, − A set of 26 genes assessed by mRNA.

Critère d'inclusion

  • Breast Cancer

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