Pre-Operative Window of ET to Inform RT Decisions (POWER II)
Recruiting · NCT06507618 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →Interventions studied
Tamoxifen, Letrozole, Anastrozole, or Exemestane
What this trial 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 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).
Who can take part
Age range
65 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 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 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
6 locations listed across 2 US states.
- Yale University - New Haven, Connecticut, United States
- University of Virginia - Charlottesville, Virginia, United States
- University of Virginia Community Health - Culpeper, Virginia, United States
- INOVA Schar Cancer - Fairfax, Virginia, United States
- Riverside Health System - Newport News, Virginia, United States
- Virginia Commonwealth University - Richmond, Virginia, United States