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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Pre-Operative Window of ET to Inform RT Decisions (POWER II)
At a glance
Conditions
Where it's being run
6 sites across 2 statesStudy leadership
- Shayna L Showalter, MD · PRINCIPAL_INVESTIGATOR · University of Virginia
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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