NCT06507618 · University of Virginia
Pre-Operative Window of ET to Inform RT Decisions (POWER II)
(POWER II)
What this study 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 the usual treatment and proceed directly to breast cancer surgery.
View original scientific description
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.
Interventions
DRUG
Tamoxifen, Letrozole, Anastrozole, or Exemestane
Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.
Primary outcome measures
Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET)
Time frame: 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 + AET
Time frame: 24 months
Proportion of participants who are treated with BCS + RT + AET as measured through the 24-month adjuvant follow-up visit
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Bilateral synchronous breast cancer
- Multicentric disease
- Prior use of SERMS or aromatase inhibitors
- History of ipsilateral breast radiation therapy
- Has a known additional malignancy that is progressing and/or requires activ
Where
- New Haven, Connecticut
- Charlottesville, Virginia
- Culpeper, Virginia
- Fairfax, Virginia
- Newport News, Virginia
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations