Menarini Group and MEDSIR Introduce Groundbreaking Phase III ADELA Study for Breast Cancer Therapy

Introduction

The international phase III clinical trial named ADELA has been recently showcased by the Menarini Group and MEDSIR at the renowned San Antonio Breast Cancer Symposium 2024 (SABCS 2024). This groundbreaking study aims to combine elacestrant, a next-generation oral selective estrogen receptor degrader, with everolimus, an mTORC1 inhibitor, to create a new therapeutic strategy against advanced ER+/HER2- breast cancer that presents with ESR1 mutations. This innovative approach seeks to address the pressing need for effective treatments for patients experiencing progression from first-line endocrine therapy.

Background

Estrogen receptor-positive (ER+) breast cancer is a significant subtype of breast cancer that often encounters resistance to standard treatments over time. ESR1 mutations typically arise in patients who have undergone endocrine therapy, leading to treatment failure and further disease progression. Recognizing this challenge, the ADELA study investigates the efficacy of a combination therapy that targets the underlying mechanisms of resistance. With approximately 50% of ER+, HER2- advanced breast cancer patients developing ESR1 mutations, the need for a solution is urgent.

The Study Structure

The ADELA trial is designed as an international, randomized, double-blind study, with the primary objective set to evaluate whether the combination of elacestrant and everolimus can effectively delay disease progression compared to elacestrant alone. Furthermore, the study will assess overall survival rates, the toxicity profile of the treatment, and its impact on the quality of life for the patients involved.

Importance of the Findings

The findings from the ADELA study can potentially pave the way for regulatory approval of the combination therapy, making it available to a broader group of patients suffering from advanced breast cancer. The international nature of the trial encompasses numerous countries, including Spain, Italy, France, Austria, the Czech Republic, Greece, Germany, and the United Kingdom, which signifies its global relevance.