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

Hologic

Status and phase

Completed

Phase 2

Conditions

DCIS

Treatments

Device: MammoSite Radiation Therapy System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00586326

MS-700

Details and patient eligibility

About

This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Full 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).

Enrollment

133 patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

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