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

Plain Language Summary

Simplified for easier understanding

This study is for older women with early-stage breast cancer to find out whether a short course of hormone-blocking therapy before surgery can help doctors decide whether radiation after surgery is truly needed. If this pre-surgery treatment shrinks the tumor significantly, some patients may be able to skip radiation altogether. **You may be eligible if...** - You are a woman aged 65 or older - You have been diagnosed with hormone receptor-positive (ER+), HER2-negative invasive breast cancer with no cancer in the lymph nodes - Your surgeon has said you are a good candidate for breast-conserving surgery (lumpectomy) - You are able to take hormone-blocking pills (tamoxifen or an aromatase inhibitor) by mouth for 3 months before your operation - You are otherwise in good health (able to carry out normal activities) **You may NOT be eligible if...** - You are not able or willing to take oral endocrine therapy for 3 months before surgery - You are not scheduled for breast-conserving surgery - You are not a candidate for radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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