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Phase 1/2 Randomized, Open-label, Three Arm Study of Neratinib (HKI-272) vs. Neratinib + Capecitabine vs. Lapatinib + Capecitabine, in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or loca...

Mise à jour : Il y a 5 ans
Référence : EUCTR2008-001662-85

Phase 1/2 Randomized, Open-label, Three Arm Study of Neratinib (HKI-272) vs. Neratinib + Capecitabine vs. Lapatinib + Capecitabine, in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or locally advanced Breast Cancer

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Extrait

Part 1: The primary objectives of Part 1 are to assess the safety and tolerability, and to define the MTD of neratinib in combination with capecitabine in subjects with advanced solid tumors. Part 2: The primary objective of Part 2 of this study is to compare the objective response rate (ORR = CR + PR) for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine vs neratinib monotherapy vs. lapatinib + capecitabine.

Critère d'inclusion

  • Solid tumors (part 1) and metastatic breast cancer (part 2)

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