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

 The patient understand that she has cancer of the breast. The patient understand that is
 offered the opportunity to participate in a registry study to collect data on the FDA
 approved device,Partial Breast Brachytherapy Applicator. Partial Breast Brachytherapy is a
 treatment method that works by delivering radiation from inside the breast directly to the
 tissue where cancer is most likely to recur. The Partial Breast Brachytherapy Applicator is a
 device that has tiny catheters or wires that fit inside the lumpectomy cavity (the space left
 after the tumor is removed). Radioactive sources (seed) are placed within the device by a
 computer controlled machine. This radioactive source will deliver the radiation therapy to
 the breast

 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.

 PROCEDURES

 If the patient agree to take part in this registry, 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.

 POTENTIAL RISKS AND DISCOMFORTS

 There is no medical risk to the patient if she takes part in this registry, as she will
 continue to receive the same medical care as provided by her medical team.

 POTENTIAL BENEFITS:

 It is not possible to state that the patient will benefit from this study. The information
 obtained from study may be used scientifically and may possibly be helpful to others.

 ALTERNATIVES TO TREATMENT

 The patient participation is voluntary and she may choose not to participate in this study or
 she may stop at any time. The patient choice will not affect doctors from providing care. The
 patient will not lose any benefits if she choose not to participate or if you withdraw from
 this study. She is free to seek care from a doctor of her choice at any time.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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