Status:
RECRUITING
Pre-Operative Window of ET to Inform RT Decisions (POWER II)
Lead Sponsor:
University of Virginia
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
65+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Early-stage, estrogen receptor positive (ER+) breast cancer is traditionally treated with breast conserving surgery (BCS), radiation therapy (RT) and 5-10 years of adjuvant endocrine therapy (AET). Ra...
Eligibility Criteria
Inclusion
- 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 SERMS 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.
Exclusion
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2034
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT06507618
Start Date
July 19 2024
End Date
March 1 2034
Last Update
September 16 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Virginia
Charlottesville, Virginia, United States, 22903
2
INOVA Schar Cancer
Fairfax, Virginia, United States, 22031
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23298