TRIO Awarded NATALEE Study, Largest Single Phase III Breast Cancer Clinical Trial in its History

Translational Research In Oncology (TRIO) today announced a collaboration with Novartis on its upcoming phase III clinical trial of ribociclib with endocrine therapy in the adjuvant treatment of HR-positive, HER2-negative early breast cancer (EBC). The trial will be called NATALEE (New Adjuvant TriAl with LEE).

"Ribociclib in combination with hormonal therapy has been demonstrated to be an effective treatment for advanced breast cancer in three large, Phase III clinical trials as well as in clinical practice around the world," says Samit Hirawat, MD, Executive Vice President, Head of Novartis Oncology Global Drug Development. "We are pleased to collaborate with TRIO, its study investigators and patients to advance ribociclib in combination with endocrine therapy as a potential new treatment option for patients with early-stage breast cancer."

This randomized, phase III study will include more than 4,000 patients from around the world. By mobilizing the strength of TRIO's investigator sites within its global network, including TRIO-US and its regional partners, TRIO aims to complete enrolment rapidly. The primary endpoint of the study is invasive disease-free survival (iDFS).

Ribociclib belongs to a class of therapies called CDK4/6 inhibitors. Cyclin-dependent kinases 4 and 6 are proteins that help regulate cell replication and proper cell cycle function. Overexpression of CDK4/6 has been observed in certain cancers, and this leads to uncontrolled cell growth contributing to tumour formation. CDK4/6 inhibitors prevent CDKs from triggering cell growth and division, leading to the death of the cell.

"This collaboration represents the largest single trial awarded to TRIO and speaks to the confidence Novartis has in our capabilities and our global clinical trial network," says Dennis J. Slamon, MD, PhD, TRIO Chairman/Executive Director and Director of Clinical Translational Research at the University of California, Los Angeles Jonsson Comprehensive Cancer Center. "Ribociclib with endocrine therapy is an exciting addition to the world of cancer therapies. Maintaining disease-free survival and quality of life in breast cancer patients guides all of our research."

TRIO's experience with breast cancer clinical trials is well-established, having been involved in the development of trastuzumab for HER2-positive breast cancer, docetaxel for early-stage breast cancer, and other CDK4/6 inhibitors. TRIO's commitment to breast cancer positions them as leaders in the field, with a long-standing desire to improve the lives of people with breast cancer.

This clinical trial will provide insight into the role of ribociclib in EBC. The efficacy, safety, and validity of ribociclib in the treatment of present and future EBC patients is the ultimate goal of TRIO and Novartis. 

Ribociclib was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

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