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

Phase 2

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Women with DCIS	MammoSite Radiation Therapy System	Women with DCIS

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	At 5 Years
Cause Specific Survival	At 5 Years
Disease Free Survival	At 5 Years
Cosmetic Evaluations Over Time	At 5 Years	As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

Locations (12): William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
St. Agnes Hospital
🇺🇸
Baltimore, Maryland, United States
MD Anderson Cancer Clinic
🇺🇸
Houston, Texas, United States
Swedish Cancer Institute
🇺🇸
Seattle, Washington, United States
Arizona Oncology Services
🇺🇸
Phoenix, Arizona, United States
Cedars Medical Center
🇺🇸
Miami Beach, Florida, United States
NY Presbyterian
🇺🇸
New York, New York, United States
Daniel Freeman Hospital
🇺🇸
Inglewood, California, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States