Pre-Operative Window of ET to Inform RT Decisions (POWER II)
ConditionBreast Cancer Female
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age65+
SponsorUniversity of Virginia
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Bilateral synchronous breast cancer
Multicentric disease
Prior use of Tamoxifen or aromatase inhibitors
History of ipsilateral breast radiation therapy
Trial design
Treatments tested in this trial
- Tamoxifen, Letrozole, Anastrozole, or Exemestane
Treatment groups
354 Participants
are divided into 2 treatment groupsLocations
6Yale University06511, New HavenConnecticut, United States
University of Virginia22903, CharlottesvilleVirginia, United States
University of Virginia Community Health22701, CulpeperVirginia, United States
INOVA Schar Cancer22031, FairfaxVirginia, United States
Sponsors and collaborators
University of Virginia
Lead sponsor
Source ClinicalTrials.gov