NATALEE Trial Evaluates Ribociclib With ET in Early Breast Cancer

Gabriel N. Hortabagyi, MD, FACP, professor of Medicine at The University of Texas MD Anderson Cancer Center, provides an overview of the phase 3 NATALEE trial (NCT03701334) evaluating the combination of ribociclib (Kisqali) with endocrine therapy as adjuvant treatment in patients with hormone receptor (HR)-positive/HER2-negative early breast cancer.

NATALEE is a multicenter, randomized, open-label, phase 3 study assessing the combination in adult patients with HR-positive/HER2-negative early breast cancer. Once enrolled, patients were given ribociclib at a dose of 400 mg daily in a 3-weeks-on-1-week off manner for 3 years.

Both arms of the study administered patients standard-of-care endocrine therapy which consisted of letrozole or anastrozole for a duration of at least 5 years plus goserelin.

The report of the second interim analysis was presented at the 2023 American Society of Clinical Oncology Annual Meeting, and Hortabagyi presented approximately 3-years of follow-up data of the phase 3 NATALEE trial at the 2023 San Antonio Breast Cancer Symposium.

Transcription:

0:09 | So, several years ago, the 3 CDK4/6 inhibitors on the market today were shown to produce significant improvements in disease-free interval, and a couple of them in overall survival in patients with hormone receptor-positive or HER2-negative metastatic breast cancer. Based on those data, we designed the NATALEE trial, which was a phase 3, randomized clinical trial for patients with early breast cancer, in which after appropriate surgery, radiation therapy and chemotherapy if appropriate, patients were randomly assigned to receive at least 5 years of adjuvant endocrine therapy, or the same endocrine therapy plus ribociclib 400 mg per day, 3 weeks on, 1 week off for 3 years.

1:09 | We started this trial in January 2019, and completed accrual of 5101 patients in April 2021. The primary efficacy variable was invasive disease-free survival…and there were a number of secondary end points, including recurrence-free survival, distant disease-free survival, overall survival, patient reported outcomes, safety and tolerability, and [pharmacokinetics].