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ACTIVE NOT RECRUITING Phase 2

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

NCT04272801 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04272801

The ClinicalTrials.gov registry entry for NCT04272801 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shayna Showalter, MD, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04272801 reports 2 study locations spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04272801?

The interventions under investigation include: tamoxifen, letrozole, anastrozole, or exemestane (DRUG), Patient reported outcomes (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04272801?

This trial is sponsored by Shayna Showalter, MD, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial