MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

Study Overview
=================
Brief Summary
-----------------
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Detailed Description
-----------------
Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Official Title
-----------------
MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

Conditions
-----------------
DCIS

Intervention / Treatment
-----------------
* Device: MammoSite Radiation Therapy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-Surgery: Unicentric pure DCIS Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI Post-Surgery: Negative histological margins confirmed prior to beginning radiation therapy. Margins are positive if there is tumor at the inked margin. Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible Clinically node negative Exclusion Criteria: Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging. Distant metastases. Invasive or in-situ lobular carcinoma (post-surgery assessment). Nonepithelial breast malignancies such as sarcoma or lymphoma. DCIS that is multicentric in the ipsilateral breast. Pregnant or lactating. Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy. Collagen vascular diseases Coexisting medical conditions with life expectancy < 2 years. Serious psychiatric or addictive disorder Previously treated contralateral breast carcinoma Synchronous bilateral breast carcinoma. Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous. Patients with diffuse disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with DCIS<br>Women with DCIS | Device: MammoSite Radiation Therapy System<br>* The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control Rate for Follow-up Period of 5 Years. | Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure. | Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | At 5 Years | 
| Cause Specific Survival |  | At 5 Years | 
| Disease Free Survival |  | At 5 Years | 
| Cosmetic Evaluations Over Time | As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint | At 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MammoSite, DCIS