MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hologic, Inc.
- Enrollment
- 133
- Locations
- 12
- Primary Endpoint
- Local Control Rate for Follow-up Period of 5 Years.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Women with DCIS
Women with DCIS
Intervention: MammoSite Radiation Therapy System (Device)
Outcomes
Primary Outcomes
Local Control Rate for Follow-up Period of 5 Years.
Time Frame: 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 Outcomes
- Overall Survival(At 5 Years)
- Cause Specific Survival(At 5 Years)
- Disease Free Survival(At 5 Years)
- Cosmetic Evaluations Over Time(At 5 Years)