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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.
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).
Primary Outcome
Change in participant response to question regarding preference for adjuvant radiation treatment
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
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 2 |
What the registry record for NCT04272801 still lists
NCT04272801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer Female
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04272801's enrollment target sits among peer trials
84 26th of 46 higher than 21 of 46 other Breast Cancer Female trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Female trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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