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
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) / Frassoldati, A; Guarneri, Valentina; Piacentini, Federico; Jovic, Gordana; Giovannelli, Simona; Oliva, C; Conte, Pierfranco. - In: CLINICAL BREAST CANCER. - ISSN 1526-8209. - STAMPA. - 8:1(2008), pp. 97-100. [10.3816/CBC.2008.n.010]
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)
FRASSOLDATI A;GUARNERI, Valentina;PIACENTINI, Federico;JOVIC, Gordana;GIOVANNELLI, Simona;CONTE, Pierfranco
2008
Abstract
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
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