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

NCT06507618 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2026-05-08

No results posted yet for this study

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).

Conditions

  • Breast Cancer Female

Interventions

DRUG

Tamoxifen, Letrozole, Anastrozole, or Exemestane

Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Shayna L Showalter, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06507618 on ClinicalTrials.gov