Pre-Operative Window of ET to Inform RT Decisions (POWER II)
Recruiting
Phase 3
Interventional Study
Breast Cancer Female
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 65 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 354 (estimated)
- Sponsor
- University of Virginia · Other
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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 a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria (summary):
* 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…
Contacts