Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Neoplasms

Breast Carcinoma In Situ

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.

MammoSite Radiation Therapy System

Oscar Streeter, MD

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

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).

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

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

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.

As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

University of Southern California

Hologic, Inc.

Enrolled subjects with MammoSite device placed

Intent to Treat

Subjects enrolled with device placed and treated with partial breast irradiation

Treated

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Nancy Chenette, Director, Clinical Affairs

Local Control Rate for Follow-up Period of 5 Years.

Overall Survival

Cause Specific Survival

Disease Free Survival

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Excellent' at 5 years

Excellent

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years

Good

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years

Fair

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years

Spots Global Cancer Trial Database for mammosite radiation therapy system