Long-term Registry Study of Pre- and Perimenopausal Women With Early Luminal Breast Cancer at Intermediate to High Clinical Risk and Low Genomic Risk Treated with Standard Endocrine Therapy and Ovarian Function Suppression

What this Trial Is About

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.

PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS