RecruitingPhase 3NCT06507618

Pre-Operative Window of ET to Inform RT Decisions (POWER II)

A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)

Sponsor

University of Virginia

Enrollment

354 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Female

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 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

Sex: FEMALEMin Age: 65 Years

Inclusion Criteria10

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 Criteria6

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.