Phase 2
Completed N=133
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
DCIS
Source: ClinicalTrials.gov NCT00586326 ↗
Enrolled (actual)
133
Serious AEs
5.1%
Results posted
Oct 2012
Primary outcomePrimary: Local Control Rate for Follow-up Period of 5 Years. — 99 percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Control Rate for Follow-up Period of 5 Years. |
99 | — |
| SECONDARY Overall Survival |
97.7 | — |
| SECONDARY Cause Specific Survival |
100.0 | — |
| SECONDARY Disease Free Survival |
98.9 | — |
| SECONDARY Cosmetic Evaluations Over Time |
42.6; 44.7; 12.8; 0.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00586326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.