Who is eligible for clinical trial NCT04272801?

Participants must meet protocol criteria for Breast Cancer Female. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04272801 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-25

Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer (NCT04272801)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Shayna Showalter, MD

🩺 Plain-English Summary (8th-Grade Level)

This is a prospective multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated with 3 months of pre-operative endocrine therapy (pre-ET) with assessment of tolerance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (6 items).

Location: University of Virginia — Charlottesville, Virginia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

(Summary):
ECOG performance status 0-2
Diagnosed with anatomic stage I, ER positive, PR positive or negative, and HER2 non amplified invasive breast cancer and clinically negative nodes; any invasive breast cancer histologic subtype may be enrolled
Tumor size ≤ 2 cm
Patient has elected BCS as surgical choice
Eligible to receive tamoxifen or an aromatase inhibitor
Ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to BCS

Usually NOT eligible if any of the following apply:

Exclusion Criteria (Summary):
Prior or current use of endocrine therapy for breast cancer
History of ipsilateral breast radiation
Pregnancy or lactation
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Current or planned use of a strong CYP2D6 inhibitor (e.g. Fluoxetine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

University of Virginia — Charlottesville, Virginia
Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗