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RECRUITING
NCT06507618
PHASE3

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

Sponsor: University of Virginia

View on ClinicalTrials.gov

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

Interventions

DRUG

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