Pre-Operative Window of ET to Inform RT Decisions (POWER II)
Recruiting now · Phase 3
Conditions studied: Breast Cancer Female
In brief
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).
Key facts
- Study ID
- NCT06507618
- Run by
- University of Virginia
- People needed
- 354
- Starts
- 2024-07-19
- Expected to finish
- 2034-03-01
- Last updated by the study team
- 2026-06-30
Who can join
Age: 65 and older. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Yale University — New Haven, Connecticut, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- University of Virginia Community Health — Culpeper, Virginia, United States (enrolling)
- INOVA Schar Cancer — Fairfax, Virginia, United States (enrolling)
- Riverside Health System — Newport News, Virginia, United States (enrolling)
- Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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