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NCT04272801 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Cancer Female, sponsored by Shayna Showalter, MD.

Active
Registry status
Phase 2
Development phase
84
Enrollment target
2
Study locations

NCT04272801: Active Phase 2 study of Breast Cancer Female, sponsored by Shayna Showalter, MD.

NCT04272801 is a Phase 2 study of Breast Cancer Female that is active but no longer recruiting, run by Shayna Showalter, MD. The registered enrollment target is 84 participants, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04272801, a Phase 2 study of Breast Cancer Female, is active but no longer recruiting, sponsored by Shayna Showalter, MD.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
84 participants
Enrollment target
2
Study locations

Study Summary

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).

Conditions Studied

Interventions

  • DRUG tamoxifen, letrozole, anastrozole, or exemestane
  • BEHAVIORAL Patient reported outcomes

Study Locations (2)

Virginia

  • University of Virginia - Charlottesville
  • Virginia Commonwealth University Massey Cancer Center - Richmond

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2020-04-07
Est. Completion 2026-06-01
Phase Phase 2

Sponsor

Shayna Showalter, MD

3 total trials

What the Registry Record Tells You About NCT04272801

The ClinicalTrials.gov registry entry for NCT04272801 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (88% lower). The listed sponsor is Shayna Showalter, MD, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer Female appearing as the primary indexed condition, and to 2 interventions - of which tamoxifen, letrozole, anastrozole, or exemestane is the first listed.

NCT04272801 reports 2 study locations spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT04272801 about?

NCT04272801 is a clinical study titled "Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer". 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 ...

What is the current status of trial NCT04272801?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2020-04-07. Estimated completion is 2026-06-01.

What conditions does trial NCT04272801 study?

This clinical trial studies the following conditions: Breast Cancer Female.

What interventions are being tested in trial NCT04272801?

The interventions under investigation include: tamoxifen, letrozole, anastrozole, or exemestane (DRUG), Patient reported outcomes (BEHAVIORAL).

Who is sponsoring clinical trial NCT04272801?

This trial is sponsored by Shayna Showalter, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04272801 being conducted?

This trial has 2 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.