drugset / Trial / NCT06507618

Pre-Operative Window of ET to Inform RT Decisions (POWER II)

NCT06507618

Phase 3 Recruiting 354 enrolled University of Virginia
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2024-07-19
Primary completion
2029-06-30
Completion
2034-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified
Subject Exemestane Small molecule
Subject Letrozole Other / unclassified
Subject Tamoxifen Small molecule