A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.

Status unconfirmed

Conditions studied: This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.

In brief

A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases. The data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.

Key facts

Study ID

NCT01813825

Run by

St. Vincent's Medical Center

People needed

300

Starts

2004-11-01

Expected to finish

2015-12-01

Last updated by the study team

2013-03-19

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be 45 years of age or older
• Be a Tis, T1, N0 M0 - American Joint Committee Classification
• Have negative surgical margins (NSABP definition) after final surgery
• Should have adequate skin spacing between balloon surface and surface of the skin (>=7mm)
• DCIS

You may not qualify if…

• Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study)
• Have collagen-vascular disease
• Have extensive intraductal component (Harvard Definition,>25% DCIS)
• Have infiltrating lobular histology

Where it is running

• St. Vincent's Medical Center — Bridgeport, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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