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

This study is for women aged 65 and older with early-stage, estrogen receptor-positive (ER+), HER2-negative breast cancer. It aims to see if giving endocrine therapy (like Tamoxifen, Letrozole, Anastrozole, or Exemestane) before surgery can help decide if radiation therapy (RT) is needed. You would either receive 3 months of this endocrine therapy before breast cancer surgery, or go straight to surgery as is standard. Researchers will look at how many participants skip radiation therapy but don't stick with their endocrine therapy, and how many receive surgery, radiation, and endocrine therapy, both measured at 24 months. The goal is to understand if this pre-surgery treatment can help avoid unnecessary radiation or ensure patients who skip radiation can tolerate their endocrine therapy.

Study design
This is a Phase III, multisite exploratory study with 354 participants. You would be randomly assigned to one of two groups: either receiving 3 months of pre-operative endocrine therapy or going directly to surgery.
What's involved
You would either take endocrine therapy for 3 months before surgery or proceed directly to breast cancer surgery. Both groups will complete patient surveys to assess tolerance and compliance with endocrine therapy.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for 24 months after treatment to measure the main study outcomes.

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NCT06507618

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

Recruiting
PHASE3Ages 65+InterventionalTreatment
University of Virginia
~354 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Tamoxifen, Letrozole, Anastrozole, or Exemestane

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET)
Measured over 24 months
+1 more outcome measured
Breast Cancer Female
6 sites across 2 states
Virginia5
Connecticut1
  • Shayna L Showalter, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

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Eligibility criteria

Inclusion

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
Patient is a candidate for radiation therapy
Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS
Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion

Bilateral synchronous breast cancer
Multicentric disease
Prior use of Tamoxifen or aromatase inhibitors
History of ipsilateral breast radiation therapy
Has a known additional malignancy that is progressing and/or requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.
Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.
  • Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET)24 months

    Proportion of participants who omit RT and are non-adherent to ET as measure through the 24-month adjuvant follow-up visit

  • Proportion of participants who are treated with Breast Cancer Surgery (BCS) + RT + AET24 months

    Proportion of participants who are treated with BCS + RT + AET as measured through the 24-month adjuvant follow-up visit