Post Market Study Using the Xoft Axxent System

Study Overview
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Brief Summary
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The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.

Detailed Description
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The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.

Official Title
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Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Electronic brachytherapy (Axxent System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >50 years Tumor with Tis, T1, N0, M0 - (AJC Classification) Invasive ductal carcinoma or ductal carcinoma in situ Negative microscopic surgical margins of at least 1mm in all directions Adequate skin spacing between balloon surface and surface of the skin - (> 7mm) Exclusion Criteria: Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention) Scleroderma, systemic sclerosis and active lupus Infiltrating lobular histology

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment. | Radiation: Electronic brachytherapy (Axxent System)<br>* 3.4 Gy per fraction for 10 fractions for a total of 34 Gy.<br>* Other names: Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Delivery of 34 Gy in 10 Fractions | Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue) | measured at end of 10th fraction, usually within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. | Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported. | Through 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage I, Stage II, Breast, Cancer