This phase I trial studies how well endocrine therapy before surgery works in informing treatment decisions before radiation therapy in patients with geriatric, estrogen receptor positive stage I breast cancer. Endocrine therapy blocks or stops the production of estrogen to help treat estrogen receptor positive breast cancer. Radiation therapy can be used after surgery to treat early stage breast cancer. Radiation therapy uses high energy rays to kill tumor cells. Patients and doctors have to make a decision about radiation therapy immediately after their surgery. This study is being done to find out if receiving endocrine therapy before the surgery would change patients' and doctors' decisions regarding radiation treatment after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04272801.
PRIMARY OBJECTIVES:
I. To assess whether pre-endocrine therapy (ET) changes an individual’s preference for adjuvant radiation treatment.
II. To assess whether pre-treatment with endocrine therapy changes the surgical oncologist’s preference for adjuvant radiation treatment.
SECONDARY OBJECTIVES:
I. To obtain preliminary estimates to assess whether patient reported outcomes during pre-ET are predictive of long-term adjuvant endocrine therapy adherence.
II. For those participants who agree to a radiation oncologist consultation, to assess whether pre-treatment with endocrine therapy changes the radiation oncologist’s preference for adjuvant radiation treatment.
III. To obtain preliminary data on the effect of pre-ET on decision outcomes for adjuvant therapy after breast conservation surgery (BCS).
EXPLORATORY OBJECTIVE:
I. To obtain exploratory data on recurrence-free survival and overall survival.
OUTLINE:
Patients receive endocrine therapy for 90 days and then undergo standard of care breast conservation surgery. Patients may then undergo standard of care radiation therapy and/or resume endocrine therapy at the discretion of the treating medical oncologist.
After completion of study treatment, patients are followed up at 2 weeks and at 6, 12, and 24 months.
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorTrish Millard
