IORT-Breast at Medical Center Navicent Health

Active, not recruiting

• Conditions: Breast Cancer Female; Early-stage Breast Cancer
• Interventions: Procedure: Lumpectomy; Radiation: Intraoperative Radiation Therapy

• Registration Number: NCT04595435
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-19
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2024-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B- Postoperative Prospective	Intraoperative Radiation Therapy	Subjects who have had IORT performed within the previous 6 month who agree to participate.
Cohort A- Preoperative Prospective	Intraoperative Radiation Therapy	Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention.
Cohort B- Postoperative Prospective	Lumpectomy	Subjects who have had IORT performed within the previous 6 month who agree to participate.
Cohort A- Preoperative Prospective	Lumpectomy	Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention.

Primary Outcome Measures

Name	Time	Method
Rate of recurrence	10 year	To determine rate of recurrence of disease at specific time period

Secondary Outcome Measures

Name	Time	Method
Treatment Abandonment	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.
Acute and late effects	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.

Trial Locations

Locations (1)

Medical Center, Navicent Health; 🇺🇸 Macon, Georgia, United States