title: 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).
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.
authors.affiliation: Division of Medical Oncology, Department of Oncology and Hematology, University Hospital, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Frassoldati
authors.forename: Valentina
authors.initials: V
authors.lastname: Guarneri
authors.forename: Federico
authors.initials: F
authors.lastname: Piacentini
authors.forename: Gordana
authors.initials: G
authors.lastname: Jovic
authors.forename: Simona
authors.initials: S
authors.lastname: Giovannelli
authors.forename: Cristina
authors.initials: C
authors.lastname: Oliva
authors.forename: Pier Franco
authors.initials: PF
authors.lastname: Conte
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D018734:Genes, erbB-2; D006801:Humans; D000077341:Lapatinib; D000077289:Letrozole; D008875:Middle Aged; D009367:Neoplasm Staging; D009570:Nitriles / Q000008:administration & dosage*; D017698:Postmenopause; D011799:Quinazolines / Q000008:administration & dosage*; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage*
chemical_list: D000970:Antineoplastic Agents; D009570:Nitriles; D011799:Quinazolines; D014230:Triazoles; D000077341:Lapatinib; D000077289:Letrozole