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)
University of Virginia
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).
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). Radiation therapy (RT) omission is an established treatment paradigm for women 65 years and older with ER+, node negative, small (≤ 3 cm) breast cancer. Despite the option for RT omission being recommended in the National Comprehensive Cancer Network (NCCN) guidelines, multiple modern studies demonstrate that a majority of older women still receive RT, raising concern for over-treatment. Conversely,…
Eligibility
- Age range
- 65+ years
- Sex
- Female
- Healthy volunteers
- No
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 o…
Interventions
- DrugTamoxifen, Letrozole, Anastrozole, or Exemestane
Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.
Locations (5)
- Yale UniversityNew Haven, Connecticut
- University of VirginiaCharlottesville, Virginia
- University of Virginia Community HealthCulpeper, Virginia
- INOVA Schar CancerFairfax, Virginia
- Virginia Commonwealth UniversityRichmond, Virginia