Frassoldati Antonio, Guarneri Valentina, Piacentini Federico, Jovic Gordana, Giovannelli Simona, Oliva Cristina, Conte Pier Franco
Division of Medical Oncology, Department of Oncology and Hematology, University Hospital, University of Modena and Reggio Emilia, Modena, Italy.
Clin Breast Cancer. 2008 Feb;8(1):97-100. doi: 10.3816/CBC.2008.n.010.
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.
许多激素受体阳性肿瘤表现出原发性或获得性耐药，这可能是由于与其他生长因子相关的转导途径（主要是表皮生长因子受体家族相关途径）存在相互作用。LETLOB研究是一项欧洲多中心、安慰剂对照、随机II期试验，针对激素敏感、HER2阴性、II-IIIA期（T>2 cm，N0-1，M0）的绝经后乳腺癌患者，在手术前给予来曲唑或来曲唑联合拉帕替尼治疗6个月。将评估临床终点（主要终点[超声客观缓解率]、次要终点[病理完全缓解率和保乳手术率、安全性以及治疗失败时间]和生物学终点[增殖和凋亡途径的中间及最终生物标志物的抑制情况以及基因谱与反应的相关性]）。
