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NCT Number: NCT04595435

IORT-Breast at Medical Center Navicent Health

Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes.

Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Early-Stage Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Medical Center, Navicent Health

Macon, Georgia, 31201, United States

About this study

Objectives: (primary and important secondary objectives) The primary objective is to determine rates of recurrence at 5, and 10 years following IORT-Breast at Navicent Health.

Secondary objectives include determination of acute and late effects of IORT-Breast at the treatment site, cosmetic outcomes and satisfaction over 10 years.

In addition, the study will determine why patients who were scheduled for IORT-Breast did not receive it after lumpectomy.

Study Design:

Prospective, observational registry.

Setting/Participants:

The study focuses on outpatients/short stay surgery performed at the Medical Center, Navicent Health, Macon, GA only.

Participants have been deemed eligible for IORT-Breast or have received IORT-Breast within the last 6 months. Key eligibility criteria for IORT- Breast includes women, aged 55 years old or greater, diagnosed with clinically node negative, grade 1 or 2 Invasive Breast Cancer with no lymphovascular invasion, that is 20mm or less in greatest dimension, Estrogen Receptor (ER) positive, HER 2 Neu Negative, and with a depth greater than 10mm from skin.

Study Interventions and Measures:

Participants will be eligible for IORT-Breast or have received IORT-Breast in the previous 6 months. Participants who were scheduled for IORT-Breast and do not receive IORT-Breast will have reasons for not receiving IORT-Breast recorded and will not be followed further. Participants receiving IORT-Breast will have treatment parameters recorded and will be followed every 6 months for 2 years and then annually until up to 10 years following treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent and HIPAA authorization
  • T1 tumor (less than or equal to 20mm in greatest diameter)
  • Unifocal
  • Histological Grade 1 or 2
  • Node Negative
  • ER +ve
  • HER-2 -ve

Exclusion criteria

  • Previous radiation therapy to the involved breast other than IORT within 6 months
  • High grade tumors (Histologic grade 3)
  • Her-2 Positive
  • Lymphovascular invasion
  • Metastatic disease
  • close proximity to or involvement of skin
  • Multifocal cancer

Treatment and study plan

Lumpectomy

Procedure

Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.

Other names: Breast Conserving Surgery

intraoperative radiation therapy

Radiation

Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure

Other names: IORT

Primary outcomes

  1. Rate of recurrence

    Time frame: 5 year

    To determine rate of recurrence of disease at specific time period

  2. Rate of recurrence

    Time frame: 10 year

    To determine rate of recurrence of disease at specific time period

Secondary outcomes

  1. Acute and late effects

    Time frame: 5 years

    To determine the rate of acute and late effects of IORT at the treatment site. Periodic review by surgeon and self reports identifying acute and late effects and calculating the rate of incidence for the treated group.

  2. Treatment Abandonment

    Time frame: 5 years

    To determine rate and reason for abandoning procedure after being scheduled for procedure. Calculating the rate of those who were scheduled to receive IORT and then did not receive the treatment as planned and reason why they did not receive the treatment.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Navicent

Registry information

Official study title

Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health

Acronym: IORT-Breast

Important dates

Study start
2019
Primary completion
2033
Study completion
2033
First posted
Oct 20, 2020
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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