MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (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).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Oscar Streeter, MD
University of Southern California
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Rhode Island Hospital||Providence, Rhode Island 02903|
|Swedish Cancer Institute||Seattle, Washington 98104|
|William Beaumont Hospital||Royal Oak, Michigan 48073|
|Cedars Medical Center||Miami, Florida 33136|
|Virginia Commonwealth University||Richmond, Virginia|
|University of Southern California||Los Angeles, California 90033|
|St. Agnes Hospital||Baltimore, Maryland 21229|
|Arizona Oncology Services||Phoenix, Arizona 85032|
|Daniel Freeman Hospital||Inglewood, California 90301|
|NY Presbyterian||New York, New York 10065|
|MD Anderson Cancer Clinic||Houston, Texas 77030|