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Letrozole versus letrozole plus Lapatinib (GW572016) in hormone-sensitive, HER2-negative operable breast cancer: a double-blind, randomized, phase II study with biomarker evaluation (EGF109077-LAP107692/LETLOB).

Author(s): Frassoldati A, Guarneri V, Piacentini F, Jovic G, Giovannelli S, Oliva C, Conte PF

Affiliation(s): Division of Medical Oncology, Department of Oncology and Hematology, University Hospital, University of Modena and Reggio Emilia, Modena, Italy.

Publication date & source: 2008-02, Clin Breast Cancer., 8(1):97-100.

Publication type: Multicenter Study; Randomized Controlled Trial

Many hormone receptor-positive tumors show primary or acquired resistance, possibly because of a crosstalk with other growth factor-related transduction pathways (mainly epidermal growth factor receptor family related). The LETLOB study is a European multicenter, placebo-controlled, randomized phase II trial in postmenopausal patients with hormone-sensitive, HER2-negative, stage II-IIIA (T > 2 cm, N0-1, M0) breast cancer, in which letrozole or the combination of letrozole plus lapatinib will be administered for 6 months before surgery. Clinical endpoints (primary [ultrasonographic objective response], secondary [rate of pathologic complete response and of conservative surgery, safety, and time to treatment failure], and biologic [inhibition of intermediate and final biomarkers of the proliferative and apoptosis pathways and gene profile correlation with response]) will be evaluated.

Page last updated: 2008-06-22

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