Pre-operative endocrine therapy for older women with early-stage breast cancer
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)
This study is testing if giving older women with early-stage breast cancer a 90-day treatment before surgery can help them tolerate the treatment better and decide if they need radiation afterwards.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 354 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (New Haven, Connecticut and 4 other locations) |
| Trial ID | NCT06507618 on ClinicalTrials.gov |
What this trial studies
This Phase III, multisite exploratory study focuses on women aged 65 and older with early-stage estrogen receptor positive (ER+) breast cancer. Participants will be randomly assigned to either receive 90 days of pre-operative endocrine therapy or proceed directly to breast cancer surgery without prior treatment. The study aims to assess the tolerance and compliance to endocrine therapy through patient-reported outcomes. The goal is to determine if pre-operative therapy can inform decisions regarding the necessity of radiation therapy post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 65 and older diagnosed with early-stage ER+ breast cancer who are eligible for breast-conserving surgery.
Not a fit: Patients with bilateral synchronous breast cancer or those who have previously received endocrine therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help reduce unnecessary radiation therapy in older women with breast cancer, leading to better treatment outcomes and quality of life.
How similar studies have performed: Previous studies, such as the POWER I trial, have shown success in using pre-operative endocrine therapy to influence treatment decisions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
New Haven, Connecticut and 4 other locations
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
- University of Virginia Community Health — Culpeper, Virginia, United States (Recruiting)
- INOVA Schar Cancer — Fairfax, Virginia, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Shayna L Showalter, MD — University of Virginia
- Study coordinator: Meagan Miller
- Email: aey8fc@uvahealth.org
- Phone: 434-243-8101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.