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 — —