Recent Updates
Recently added Catalysts

MammoSite Radiation Therapy System

Phase 2

DCIS | Unknown | Other |Hologic, Inc.|Last Updated: Nov 6, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment133

FDA Designations

No designations recorded

Clinical trial landscape

MammoSite Radiation Therapy System · 1 trial · 1 indication

Phase 2 1
NCT00586326MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-SituDCIS
COMPLETED133 Analytics
PHASE2COMPLETED
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
DCIS
NCT00586326133
Unlock trial analytics

Study Endpoints

Primary Endpoints

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

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 Endpoints

Overall Survival
At 5 Years
Cause Specific Survival
At 5 Years
Disease Free Survival
At 5 Years
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Women with DCISEXPERIMENTALWomen with DCIS

Interventions

NameTypeDescription
MammoSite Radiation Therapy SystemDEVICEThe 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.
Unlock Study Design Details

Eligibility Criteria

Age Range45 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites12

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...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about MammoSite Radiation Therapy System

What is MammoSite Radiation Therapy System used for?

MammoSite Radiation Therapy System is used for ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer. It is a radiation therapy system designed to deliver treatment directly to the area where the cancer was removed, potentially reducing the need for whole-breast radiation.

Who makes MammoSite Radiation Therapy System?

MammoSite Radiation Therapy System is developed by Hologic, Inc., a company traded on the NASDAQ under the ticker symbol HOLX. Hologic specializes in women's health technologies, including diagnostic and surgical products.

What phase is MammoSite Radiation Therapy System in?

MammoSite Radiation Therapy System is in Phase 2 clinical development. It is an investigational device and has not been approved by the FDA for the treatment of DCIS. The Phase 2 trial has been completed, but it remains in clinical development.

What clinical trials is MammoSite Radiation Therapy System in?

MammoSite Radiation Therapy System has one completed clinical trial, NCT00586326, titled 'MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ.' This Phase 2 study enrolled 133 female participants aged 45 years and older in the United States.

Is MammoSite Radiation Therapy System a randomized controlled trial?

No, the clinical trial for MammoSite Radiation Therapy System is not randomized and does not use a control group. It is an uncontrolled study, meaning all participants receive the same treatment without comparison to a placebo or standard therapy.