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Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

NCT02482376 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-17

Study results available
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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

Conditions

Interventions

RADIATION

Stereotactic body radiotherapy ( SBRT)

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

Sponsors & Collaborators

  • Gateway for Cancer Research

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Rachel Blitzblau, MD PhD · Duke Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-21
Primary Completion
2025-03-10
Completion
2032-03-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02482376 on ClinicalTrials.gov