A phase III multicenter randomized open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive HER2-negative early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).

Brief description of study

The purpose of the trial is to evaluate the efficacy and the safety of ribociclib when given in combination with endocrine (hormonal) therapy, compared to endocrine therapy alone for patients: • diagnosed like you with early breast cancer (whose breast cancer has been recently diagnosed) • who had a tumor removed which is positive for hormone receptors (proteins found in the surface of breast cancer cells that pick up hormone signals telling the cells to grow) and negative for HER2 (meaning that breast cancer cells do not have a large amount of a protein called HER2 on their surface). This type of breast cancer is called HR+/HER2-.

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