Randomized Trial Comparing Endocrine Therapy Use Versus Omission in Patients 70 Years and Older With Lower Risk Hormone Receptor-Positive Breast Cancer

What this Trial Is About

This research aims to evaluate the harms and benefits of endocrine therapy in patients aged 70 years or older with lower-risk stage 1 hormone receptor-positive HR breast cancer. The current standard care includes breast-conserving surgery followed by radiotherapy and at least 5 years of endocrine therapy. However, in older patients, the benefit of endocrine therapy may be reduced due to higher risks of death from other causes and the presence of other health conditions that could affect quality of life and functional status. Participants will be randomly assigned to one of two groups either omission of endocrine therapy or administration of endocrine therapy for at least 5 years. Prior to this, they must have received standard local treatment, including breast-conserving surgery followed by radiotherapy or total mastectomy. The study is multicenter and randomized to assess the balance of benefits and harms associated with endocrine therapy in this older population. Throughout the study, participants will be followed for up to 5 years. Researchers will assess a hierarchical composite endpoint including overall survival, invasive disease-free survival, metastatic disease-free survival, and quality of life. Additional evaluations will include breast cancer-specific survival, treatment side effects, changes in geriatric health domains, adherence to endocrine therapy, and patient-reported symptoms such as hot flashes and joint pain. Quality of life questionnaires and belief assessments about therapy will be collected at multiple time points to monitor impact and treatment experiences.

Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer