Breast Cancer Clinical Trial

Post Market Study Using the Xoft Axxent System

Summary

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

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

44

Study ID:

NCT01017549

Recruitment Status:

Completed

Sponsor:

Xoft, Inc.

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There are 10 Locations for this study

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Mills Peninsula Hospital
San Mateo California, 94401, United States
Wellstar-Kennestone Cancer Center
Marietta Georgia, 30060, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Little Company of Mary Hospital
Evergreen Park Illinois, 60805, United States
Holy Cross Medical Center
Silver Spring Maryland, 20910, United States
Beth Israel Medical Center
New York New York, 10003, United States
Dickstein Cancer Center- White Plains Hospital
White Plains New York, 10601, United States
Oklahoma University Health Science Center
Oklahoma City Oklahoma, 73104, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

44

Study ID:

NCT01017549

Recruitment Status:

Completed

Sponsor:


Xoft, Inc.

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