Dr. Andre on Rationale for SOLAR-1 Trial in Breast Cancer

Fabrice Andre, MD, PhD, professor of medical oncology, Institut Gustave Roussy, Villejuif, France, discusses the goals of the SOLAR-1 trial evaluating alpelisib plus fulvestrant (Faslodex) in patients with advanced breast cancer. The latest data were presented at the 2018 ESMO Congress.

Patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer generally present with poor outcomes, Andre says. The median survival for these patients is 14 months and the vast majority of patients will develop progressive disease after 2 years on endocrine therapy and a CDK4/6 inhibitor. For these reasons, there is a need to develop new therapies for this subset of patients—particularly the 40% who harbor the PIK3CA gene—to improve outcomes.

Eligible patients were postmenopausal women or men with HR-positive, HER2-negative metastatic breast cancer who were previously treated with an aromatase inhibitor. The primary endpoint of SOLAR-1 was progression-free survival in the patients with PIK3CA mutations.