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

Trial Details

NCT ID
NCT06507618
Phase
PHASE3
Sponsor
University of Virginia
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Tamoxifen, Letrozole, Anastrozole, or Exemestane
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Charlottesville, Virginia, United States|38.02931,-78.47668
  • Culpeper, Virginia, United States|38.47318,-77.99666
  • Fairfax, Virginia, United States|38.84622,-77.30637
  • Newport News, Virginia, United States|36.98038,-76.42975

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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