Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00586326 | MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ | PHASE2 | COMPLETED | 133 | — | — | Aug 1, 2003 | Apr 1, 2011 | Nov 6, 2012 | 12 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Women with DCIS | EXPERIMENTAL | Women with DCIS |
| Name | Type | Description |
|---|---|---|
| MammoSite Radiation Therapy System | DEVICE | The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity. |
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 t...