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Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma

NCT03612648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2026-05-05

No results posted yet for this study

Summary

The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).

Conditions

Interventions

RADIATION

Three Fraction Accelerated Partial Breast Irradiation

* TRI-APBI simulation must take place no more than 8 weeks from final definitive breast surgery * Machines that could be used include: SAVI applicator, The ViewRay System for Radiation Therapy, The ViewRay (MRIdian) Linac System, Halcyon, True Beam, True Beam STx, Edge Radiotherapy Delivery System

PROCEDURE

Partial mastectomy

-Standard of Care

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Imran Zoberi, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2026-04-28
Completion
2026-04-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03612648 on ClinicalTrials.gov