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Pre-Operative Window of ET to Inform RT Decisions (POWER II)
Sponsor: University of Virginia
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).
Official title: 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)
Key Details
Gender
FEMALE
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
354
Start Date
2024-07-19
Completion Date
2034-03-01
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
Tamoxifen, Letrozole, Anastrozole, or Exemestane
Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.
Locations (4)
University of Virginia
Charlottesville, Virginia, United States
University of Virginia Community Health
Culpeper, Virginia, United States
INOVA Schar Cancer
Fairfax, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States