MedTrace Logo

Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer

NCT03137693 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-23

Study results available
· View outcomes & findings →

Summary

This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically focusing on its ability to reduce the chances that additional breast surgery will be needed, reducing the amount of breast/heart/lung tissue that is irradiated, and to study the tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

Conditions

Interventions

OTHER

Standard of Care Schedule Variation: SABR

SABR will be delivered over 3 days, prior to surgery.

PROCEDURE

Breast-conserving Surgery

Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Michael Montejo · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2019-11-01
Completion
2020-01-27

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 NCT03137693 on ClinicalTrials.gov