Agendia Announces First Patient Enrolled in Prospective LESS Clinical Study, Sponsored by Unicancer, to De-escalate Endocrine Therapy in Women with Early Breast Cancer

On November 16, 2022 Agendia, Inc., a commercial-stage company focused on assessing an individual tumor’s risk of metastasis and the molecular subtyping reasons for its growth, reported the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia (Press release, Agendia, NOV 16, 2022, View Source [SID1234624169]). In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study aims to enroll 696 patients via 45 sites within the French breast cancer intergroup Unicancer (UCBG) by October 2024.

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"We are excited to identify early breast cancer tumors and further investigate the ability to reduce endocrine therapy duration, in an effort to minimize significant and varying side effects, while maintaining high survival rates," said Fabrice André, MD, PhD, Professor in the Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France and Co-coordinating Investigator of the study.

Elise Deluche, MD, Deputy Head of Department at Centre Hospitalier Universitaire de Limoges and Co-coordinating Investigator of the study, added, "Enabling personalized treatments to prevent over- and undertreatment in breast cancer care could give women freedom from intensive long-term treatment regimens that may not increase their chance of cure."

Previous studies have shown patients with HR+/HER2- breast cancer with a MammaPrint Ultra Low result can have an excellent prognosis at 20 years with reduced endocrine therapy.

"The LESS study is an important addition to Agendia leading the field in uncovering robust insights for patients and their providers to tailor treatments unique to every tumor," said William Audeh, MD, Chief Medical Officer at Agendia. "Through our partnership with Unicancer, we are expanding knowledge on the complexity of breast cancer and enabling further personalized treatments in cancer care."

Agendia’s singular focus on breast cancer facilitates continued investment in global research to unravel the intricacies of precision medicine and drive personalized treatment planning for women with breast cancer. This study reinforces Agendia’s commitment to practice changing research that will aid decision-making, aimed at improving outcomes.