A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)
This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups: Intervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery. Both arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).
• Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer and clinically negative nodes
• ECOG performance status 0-2
• Females, aged ≥ 65 years
• Patient is eligible for BCS and opted for BCS
• Patient is a candidate for radiation therapy
• Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
• Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS
• Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study