NATALEE Trial Evaluates Ribociclib With ET in Early Breast Cancer

Opinion
Video

Gabriel N. Hortabagyi, MD, FACP, provides an overview of the phase 3 NATALEE trial evaluating the combination of ribociclib with endocrine therapy as adjuvant treatment in patients with hormone receptor-positive/HER2-negative 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].

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