CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 110 enrolled
Drug / intervention
Stereotactic body radiotherapy ( SBRT)radiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02482376
NCT02482376Phase 2Active
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A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response

Duke University·interventional·Posted Jun 26, 2015·Updated Mar 17, 2026

In Brief

A Phase 2 clinical trial evaluating Stereotactic body radiotherapy ( SBRT) for Breast Cancer. Active but no longer recruiting, targeting 110 participants across 1 site.

Detailed Summary

This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100). The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsGateway for Cancer Research

Timeline

Phase 2Active
20162017201820192020202120222023202420252026202720282029203020312032
First PostedJun 26, 2015
Enrollment StartOct 21, 2015
Primary CompletionMar 10, 2025
Study CompletionMar 10, 2032
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 11.0 years ago

Interventions

Stereotactic body radiotherapy ( SBRT)radiation

Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer