45 Years
N/A
Female
This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.
Trial Information
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
Type of Study:
Observational [Patient Registry]
Study Design:
Time Perspective: Prospective
Outcome Measure:
A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
Outcome Description:
The efficacy of the treatment will be measured by using the overall survival. The following endpoints will also be reported and analyzed:Disease Free Survival, Cause Specific Survival, Ipsilateral Breast Failure, Contralateral Breast Failure.
Outcome Time Frame:
1-4 weeks
Safety Issue:
No
Principal Investigator
Deborah Fang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Vincent's Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
SVMC 104
NCT ID:
NCT01813825
Start Date:
November 2004
Completion Date:
December 2015
Related Keywords:
- This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.
- Mammosite
Name | Location |
|---|---|
| St. Vincent's Medical Center | Bridgeport, Connecticut 06606 |
