Mura, Silvia (2010) Ruolo del Lapatinib nel trattamento adiuvante del carcinoma mammario HER-2 positivo. Doctoral Thesis.
Aim: HER2 receptor is a molecular target for breast cancer therapy. Two drugs acts against this receptor: Trastuzumab, a monoclonal antibody efficacy both in metastatic and adiuvant setting and Lapatinib, an orally kinase inhibitor both HER1 and HER2 receptors, approved for HER2-positive metastatic breast-cancer. The study establish efficacy and safety of Lapatinib in early stage HER2 over-expressing breast cancer and examines prognostic and predictive role of HER2 and HER1 receptors. Methods: Women with early-stage HER2 positive breast cancer, not previously treated with trastuzumab, but pretreated with adjuvant chemotherapy, were randomly assigned to receive Lapatinib 1500 mg or placebo orally once daily, for 12 months or until disease recurrence. Primary endpoint was disease-free survival (DFS). Safety and overall survival (OS) were secondary endpoints.
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