Optimizing Treatment for Early Stage Triple-Negative Breast Cancer with High Immune Cell Levels Comparing Surgery and Radiation with or without Chemotherapy

What this Trial Is About

Researchers are investigating whether chemotherapy can be safely skipped for patients with certain favorable features of low stage triple-negative breast cancer after surgery and radiation. The study aims to see if avoiding chemotherapy improves patients quality of life. Participants decide with their doctors whether to have chemotherapy or not as part of their treatment. Participants receive surgery and radiotherapy based on local or national guidelines. One group will have chemotherapy omitted, while another group will receive chemotherapy in addition to surgery and radiotherapy. The study compares these two approaches to understand treatment outcomes. Participants will be monitored for up to 96 months to track disease recurrence and survival. Quality of life, fear of recurrence, health worries, and cost effectiveness will be assessed up to 2 years after inclusion. Various questionnaires and clinical evaluations will be used to measure these outcomes and ensure participant safety throughout the study.

OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes