Available in Brazil, Argentina, United States, Mexico
This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and
safety of gedatolisib plus fulvestrant combined with a CDK4/6 inhibitor (Investigator's
choice of palbociclib or ribociclib) for the treatment of patients with advanced
(inoperable) or metastatic hormone receptor positive, human epidermal growth factor
receptor 2 negative (HR+/HER2-) breast cancer whose disease has progressed during or
within 12 months of adjuvant treatment with endocrine therapy (either an AI or
tamoxifen), and who have not received prior systemic therapy for ABC. Gedatolisib is an
intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor.
Fulvestrant is a selective estrogen receptor degrader (SERD). Following completion of the
safety run-in phase to determine the gedatolisib dose with ribociclib, subjects will be
assigned to 1 of 2 cohorts based on their PIK3CA status and then randomized to either the
investigational treatment arm (gedatolisib with fulvestrant and ribociclib or
palbociclib) or standard-of-care control arm (fulvestrant and ribociclib or palbociclib).
27Research sites
674Patients around the world