NEW YORK – Natera said on Monday that it enrolled the first participants into a clinical trial that uses the firm's Signatera circulating tumor DNA-based minimal residual disease assay to evaluate the feasibility of therapy de-escalation in HER2+ metastatic breast cancer.
The multicenter Phase HEROES study aims to determine whether it is possible to identify patients for whom treatment can be temporarily or permanently discontinued without impacting their prognosis.
The France-based study seeks to recruit approximately 170 metastatic HER2+ breast cancer patients who have been on standard-of-care HER2-targeted therapies for at least two years. Patients who are Signatera-negative at baseline will stop treatment and undergo monitoring via Signatera and diagnostic imaging, with the primary endpoint being progression-free survival after one year. Participants who show radiological progression or who become Signatera-positive during the trial will resume therapy.
The study is sponsored by French hospital group Unicancer with financial support from the French Ministry of Health through the Hospital Clinical Research Program.
"Safely discontinuing treatment has been a long-lasting dilemma in HER2 metastatic breast cancer," Angel Rodriguez, senior medical director of oncology at Natera, said in a statement. "With Signatera monitoring, we hope oncologists can identify the patients without detectable disease who may be able to avoid additional therapy that can be costly and potentially harmful to their care."