This single arm study evaluates the use of pre-operative endocrine therapy in women with early stage ER+ breast cancer who are 65 years or older and are recommended for lumpectomy. The purpose of this study is to see if tolerance of pre-operative endocrine therapy helps inform decisions on whether or not to omit radiation. Participants will be treated with the novel approach of 3 months of pre-operative endocrine therapy, so that the participants and providers will have some indication of tolerance prior to making a decision about radiation omission. Tolerance of the endocrine therapy will be assessed by patient reported outcome (PRO) measures during pre-operative and adjuvant endocrine therapy treatment periods. Breast cancer participants and their surgical oncologists will be asked their preference regarding radiation therapy before starting endocrine therapy and again after completing the 3 months of endocrine therapy at the time of their pre-operative visit. They will make a determination regarding radiation therapy in conjunction with their physicians as per standard care. The hypothesis is that knowledge of tolerance of endocrine therapy will influence the decision by the patient and the surgical oncologist regarding whether or not to elect radiation omission.
The study involves 4 clinic visits before surgery and radiation and 4 visits over 2 years after surgery and radiation. All visits occur during routine cancer treatment visits; no additional visits are required. Participation involves medical history review and physical exam. Questionnaires are also a part of this study. Participant’s insurance company will be billed for medication, tests and procedures as applicable.
A description of this clinical trial is available at https://www.clinicaltrials.gov/ct2/show/NCT04272801.