Real-world Study of Trastuzumab Deruxtecan Treatment in Women with HR-positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy

What this Trial Is About

Researchers are studying real-world treatment patterns, patient characteristics, survival outcomes, and safety of Trastuzumab Deruxtecan T-DXd in women with hormone receptor-positive metastatic breast cancer mBC that is HER2-low or HER2-ultralow. This study focuses on patients previously treated with endocrine therapy and aims to provide data from Gulf Cooperation Council countries to improve treatment strategies and clinical guidelines for mBC in the region. This observational study monitors patients who have initiated T-DXd treatment as part of routine care, including those who started the drug up to 30 days before consenting to participate. It includes women aged 18 years or older with confirmed HR-positive, HER2-low or ultralow metastatic breast cancer who have not received chemotherapy in the metastatic setting. The study collects data over 18 months on treatment patterns, safety, and progression-free survival. Participants are observed while receiving their usual medical care with T-DXd, without additional intervention by the study team. Researchers collect information on patient characteristics, treatment details, safety events, and time to next treatment. The main outcome measured is real-world progression-free survival at 18 months, along with safety profiles and treatment patterns. The study is expected to last until March 2029, supporting improved outcomes through real-world evidence.

BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy