Dr. Bartsch on the Real-World Evaluation of the ELEANOR Study in HR+/HER2-Overexpressed Breast Cancer

Rupert Bartsch, MD, an associate professor, a codirector of the Brain Metastases Program, a consultant for hematology and medical oncology, Department of the Medicine, the Clinical Division of Oncology, Medical University of Vienna, discusses interim findings produced from the real-world use of neratinib (Nerlynx) in select patients with hormone receptor (HR)-positive, HER2-overexpressed breast cancer.

The ongoing, prospective, non-interventional, ELEANOR study (NCT04388384) evaluates the real-world use of neratinib in patients with stage I, II, or III HR-positive, HER2-overexpressed breast cancer. Moreover, patients must have completed adjuvant trastuzumab (Herceptin)-based therapy no more than 1 year ago.

The primary end point of the ELEANOR study was to evaluate the rate of patient compliance to treatment with neratinib. The patient was considered as being compliant and reaching this primary end point if they have taken the recommended dosing of neratinib for no less than 75% of the treatment time.

Investigators conducted an interim analysis of 200 patients and evaluated patient characteristics in relation to treatment strategies. Research showed that there was an upward trend of patients who had escalated doses of neratinib over time, Bartsch says. Patient characteristics were consistent with previously gathered data, Bartsch adds.

Also observed were patients who were given neoadjuvant treatment. When evaluating this patient group, a majority of patients subsequently received treatment with trastuzumab (Herceptin) and pertuzumab (Perjeta) or ado-trastuzumab emtansine (T-DM1; Kadcyla), he continues. Conversely, of the patients who underwent upfront surgery and adjuvant treatment, most received single-agent trastuzumab. This is expected, because these patients did not necessitate dual HER2 blockage, Bartsch explains.

These results indicate the continued routine use of extended neratinib treatment in the neoadjuvant setting for this patient population.