Safety and activity of single-agent giredestrant (GDC-9545) from a phase Ia/b study in patients (pts) with estrogen receptor-positive (ER ), HER2-negative locally advanced/metastatic breast cancer (LA/mBC).
Komal L Jhaveri, Valentina Boni, Joohyuk Sohn, Rafael Villanueva-Vásquez, Aditya Bardia, Peter Schmid, Elgene Lim, Jaymin M Patel, Jose Alejandro Perez-Fidalgo, Sherene Loi, Seock-Ah Im, Smita Kshirsagar, Mary R Gates, John Bond, Jennifer Eng-Wong, Ching-Wei Chang, Nicholas C Turner, Elena Lopez Miranda, Laura García-Estévez, Meritxell Bellet
Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2021
1017 Background: Targeting ER activity and/or E synthesis is a mainstay of ER+ BC treatment, but many pts relapse during/after adjuvant endocrine therapy (ET) or develop resistance via ESR1 mutations that drive E-independent transcription and proliferation. Most tumors remain ER signaling-dependent and pts may respond to second-/third-line ET after disease progression (PD) on prior therapies (Di Leo 2010; Baselga 2012). Giredestrant, a highly potent, nonsteroidal oral selective ER degrader, achieves robust ER occupancy, is active despite ESR1 mutations, and was well tolerated ± palbociclib with encouraging antitumor activity in the nonrandomized, open-label, dose-escalation and -expansion, ..View full abstract