Roisin M. Connolly, MB BCh
A dual approach to overcoming resistance to endocrine therapy in patients with advanced hormone receptor (HR)–positive breast cancer is under investigation in a phase III trial that adds the novel drug entinostat to standard exemestane therapy after disease progression.
“Recent combinations of agents have indicated a progression-free survival [PFS] advantage— some very significant—and have led to FDA approval, but none of them have yet shown an overall survival advantage, so we’re very excited about running this phase III study and we hope that it will confirm the results,” said Connolly, who is an assistant professor of Oncology at Johns Hopkins Medicine in Baltimore.
The 2 oral medications are administered on a 28-day cycle. All patients receive 25-mg exemestane daily. Participants in the experimental arm receive 5-mg entinostat on days 1, 8, 15, and 22, while patients in the control arm receive a placebo.
The trial is open to patients with HR-positive, HER2-negative advanced or metastatic breast cancer whose disease has progressed after taking a nonsteroidal aromatase inhibitor (AI). Patients who have been treated with a CDK inhibitor, fulvestrant, everolimus, or even a limited amount of prior exemestane are eligible to participate, said Connolly. Additionally, women of any menopausal status and men with advanced breast cancer would be considered for the study.
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