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)

Clin Breast Cancer. 2008 Feb;8(1):97-100. doi: 10.3816/CBC.2008.n.010.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Double-Blind Method
  • Female
  • Genes, erbB-2
  • Humans
  • Lapatinib
  • Letrozole
  • Middle Aged
  • Neoplasm Staging
  • Nitriles / administration & dosage*
  • Postmenopause
  • Quinazolines / administration & dosage*
  • Treatment Outcome
  • Triazoles / administration & dosage*

Substances

  • Antineoplastic Agents
  • Nitriles
  • Quinazolines
  • Triazoles
  • Lapatinib
  • Letrozole