Clinical trial · Interventional
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)
NCT00586326CI-TRIAL-00008422DCIScompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MammoSite Radiation Therapy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women with DCIS
- description
- Women with DCIS
- interventionNames
- Device: MammoSite Radiation Therapy System
Primary outcomes (1)
- measure
- Local Control Rate for Follow-up Period of 5 Years.
- timeFrame
- 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.
- description
- 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 (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.