Actively Recruiting
Pre-Operative Window of ET to Inform RT Decisions (POWER II)
Led by University of Virginia · Updated on 2026-05-08
354
Participants Needed
5
Research Sites
501 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pre-Operative Window of ET to Inform RT Decisions (POWER II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer with clinically negative lymph nodes
- ECOG performance status between 0 and 2
- Female aged 65 years or older
- Eligible for and opted to receive breast conserving surgery (BCS)
- Candidate for radiation therapy
- Candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
- Able to take oral medication and willing to follow endocrine therapy for 3 months before surgery
- Agree to follow lifestyle considerations throughout the study
- Provided signed and dated informed consent
- Willing to comply with all study procedures and available for the study duration
You will not qualify if you...
- Bilateral synchronous breast cancer
- Multicentric breast disease
- Prior use of Tamoxifen or aromatase inhibitors
- Previous radiation therapy to the same breast (ipsilateral)
- Known additional malignancy that is progressing or requires active chemotherapy or radiation, unless deemed stable and low risk by investigator
- Current or planned use of strong CYP2D6 inhibitors and unable to receive endocrine therapy agents not using this pathway
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
3
University of Virginia Community Health
Culpeper, Virginia, United States, 22701
Actively Recruiting
4
INOVA Schar Cancer
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Meagan Miller
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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