Real World Data and Long-term Follow-up of Premenopausal Women With Luminal Early Breast Cancer at Intermediate to High Clinical and Low Genomic Recurrence Risk Treated by Standard-of-Care Endocrine Therapy and Ovarian Function Suppression or Chemotherapy Followed by Endocrine Therapy

What this Trial Is About

Researchers are studying pre- and perimenopausal women with estrogen- andor progesterone-receptor-positive, HER2-negative early breast cancer who have intermediate to high clinical risk but low genomic risk of recurrence according to MammaPrint. This observational registry aims to understand the real-world use of ovarian function suppression OFS combined with endocrine therapy, especially in relation to chemotherapy use and secondary amenorrhea. The study also examines the impact of various clinical and genomic factors on treatment outcomes and quality of life. Participants receive standard-of-care treatments including endocrine therapy with or without ovarian function suppression and possibly chemotherapy, based on individual risk assessments. The registry collects data on treatment paths, adherence to therapy, and the use of ovarian function suppression over time. Quality of life is assessed regularly using specific questionnaires at multiple time points up to 5 years, and treatment adherence is monitored for up to 10 years. Throughout the study, researchers gather detailed baseline, treatment, and relapse information. They measure outcomes such as 5-year distant recurrence-free interval and monitor quality of life through validated questionnaires at intervals ranging from every 3 months in the first year to yearly up to 5 years. Long-term follow-up includes adherence tracking and evaluation of molecular and pathological markers over 10 years, providing insights into treatment effectiveness and patient well-being in real-world conditions.

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