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

RecruitingPhase 3Ages 65 Years - anyFemaleUniversity of Virginia
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In plain words

What the trial is, and whether it could suit you

This is a Phase III, multisite exploratory study for women โ‰ฅ 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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Tamoxifen, Letrozole, Anastrozole, or Exemestane
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Where

6 sites
Yale University
New Haven, United States
University of Virginia
Charlottesville, United States
University of Virginia Community Health
Culpeper, United States
INOVA Schar Cancer
Fairfax, United States
Riverside Health System
Newport News, United States
Virginia Commonwealth University
Richmond, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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