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Estudio de Fase I/II de HKI-272 en combinación con trastuzumab (Herceptin) en sujetos con cáncer de mama avanzado A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subject...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003215-52

Estudio de Fase I/II de HKI-272 en combinación con trastuzumab (Herceptin) en sujetos con cáncer de mama avanzado A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer

Femme Homme

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Extrait

Primary objectives: Part 1: To assess the safety and tolerability, and to define the MTD of orally administered HKI-272 in combination with trastuzumab in subjects with advanced breast cancer. Part 2: To determine the 16 week progression free survival (PFS) rate for subjects with advanced breast cancer treated at the MTD with HKI-272 and trastuzumab.

Critère d'inclusion

  • Advanced HER2 breast cancer. HER2 is a member of the epidermal growth factor (EGFR) family of receptors involved in cell proliferation, tumorigenesis, and metastasis and abnormally expressed in multiple tumor types. EGFR may also be over-expressed in breast cancer, play a role in tumorigenesis, and also confers a worse prognosis. Coexpression of EGFR family (HER1, 2 and 3) has been associated with a negative synergistic effect on 15-year disease specific survival of breast cancer patients

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