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

Hologic, Inc.133 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

DCIS

Interventions

MammoSite Radiation Therapy SystemDEVICE

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.

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (12)

Arizona Oncology Services

Phoenix, Arizona, United States

Daniel Freeman Hospital

Inglewood, California, United States

University of Southern California

Los Angeles, California, United States

Outcomes

Primary Outcomes

Local Control Rate for Follow-up Period of 5 Years.

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.

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.

Secondary Outcomes

Overall Survival

Time frame: At 5 Years

Cause Specific Survival

Time frame: At 5 Years

Disease Free Survival

Time frame: At 5 Years

Cosmetic Evaluations Over Time

As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

Time frame: At 5 Years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.