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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)

Objective

To determine whether treatment with pre- ET compared to standard of care results in a decrease in treatment with BCS alone.

Protocol #

POWER-II

Trial Phase:

Phase III

Principal Investigator:

McGuire, Kandace

Cancer Type
  • Breast
Study Site
  • Virginia Commonwealth University

Diagnosis of ER+, PR+/-, and HER2- (according to the 2018 ASCO/CAP guidelines for HER2 testing54) non amplified invasive breast cancer and clinically negative nodes. A tumor is considered ER+ if there is ≥10% expression of ER.
a. Histologic Subtypes: Any invasive breast cancer histologic subtype may be enrolled.
b. Tumor size based on diagnostic breast imaging: ≤3 cm
i. T size ≤ 2.0 cm: any grade (1-3)
ii. T size 2.1-3.0 cm: grade 1 or 2 and no lymphovascular invasion (LVI)
iii. Tumor size will be estimated via review of diagnostic imaging. When there is a size discrepancy on different imaging modalities, treating investigator may determine which best estimates actual tumor size and participant eligibility.
c. Multifocal Disease Criteria: Primary tumor and satellite lesion are allowed if the primary tumor meets other inclusion criteria and a single lumpectomy is planned.
Females, aged >/= 65 years

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Lindsey Gwaltney, MS, RN
    Phone: +1 804-628-2112
    Email Study Contact

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