Department of Oncology, Hospital Clínico Universitario of Valencia, INCLIVA Biomedical Research Institute, 46010 Valencia; GEICAM Spanish Breast Cancer Group, 28703 Madrid, Spain.
Department of Oncology & Hematology (DIPO), University of Milan & Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, 20122, Italy.
Future Oncol. 2022 Jun;18(19):2339-2349. doi: 10.2217/fon-2022-0045. Epub 2022 Apr 25.
ALPHABET is a randomized phase III trial assessing alpelisib + trastuzumab with or without fulvestrant in previously treated HER2-positive -mutated advanced breast cancer. Patients will be included in two cohorts according to hormone receptor (HR) status. In the experimental arms, patients in the HR-negative cohort will receive trastuzumab + alpelisib, and patients in the HR-positive cohort will receive the same treatment plus fulvestrant. Patients in the control arms will receive trastuzumab + physician's choice chemotherapy (eribuline, capecitabine or vinorelbine). Key eligibility criteria include 1-4 previous lines of anti-HER2 therapy and prior trastuzumab emtansine. The primary end point is investigator-assessed progression-free survival. The study aims to recruit a total of 300 patients.
ALPHABET 是一项随机 III 期临床试验，旨在评估 alpelisib+曲妥珠单抗联合或不联合氟维司群治疗既往治疗过的 HER2 阳性 -突变型晚期乳腺癌。患者将根据激素受体（HR）状态分为两个队列。在实验组中，HR 阴性队列的患者将接受曲妥珠单抗+alpelisib 治疗，HR 阳性队列的患者将接受相同的治疗加氟维司群。对照组的患者将接受曲妥珠单抗+医生选择的化疗（艾瑞布林、卡培他滨或长春瑞滨）。主要入选标准包括接受过 1-4 种抗 HER2 治疗和曲妥珠单抗恩坦辛。主要终点是研究者评估的无进展生存期。该研究旨在招募总共 300 名患者。
