Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®

Running, not enrolling · Not applicable

Conditions studied: Invasive Ductal Carcinoma, Ductal Carcinoma in Situ

In brief

The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.

Key facts

Study ID

NCT01644669

Run by

Xoft, Inc.

People needed

1200

Starts

2012-05-08

Expected to finish

2029-12-31

Last updated by the study team

2025-01-31

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have provided written Informed Consent
• Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
• Subject must be female ≥ 40 years of age
• Subject's tumor(s) must be < 3.0 cm in greatest diameter by pre-operative assessment
• Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
• Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria
• Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
• Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period

You may not qualify if…

• Subject is pregnant or nursing
• Subject has significant auto-immune disease
• Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
• Subject has biopsy-proven multifocal breast cancer
• Subject has multi-centric breast cancer
• Subject has known lympho-vascular invasion
• Subject has invasive lobular cancer
• Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
• Subject has a history of recurrent breast cancer in the ipsilateral breast
• Subject has had previous radiation exposure of the involved breast
• Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for Subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
• Subject has contraindications for radiation
• Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
• Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for 3 months prior to IORT.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• UCLA — Los Angeles, California, United States
• Tri-City Medical Center — Oceanside, California, United States
• Diablo Valley Oncology Hematology Medical Group — Pleasant Hill, California, United States
• Western Surgical Care, PC — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Florida Hospital Celebration Health — Celebration, Florida, United States
• Doctors Hospital — Coral Gables, Florida, United States
• Martin Health System Center for Clinical Research — Stuart, Florida, United States
• Rush University — Chicago, Illinois, United States
• Lutheran Hospital of Indiana — Fort Wayne, Indiana, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• MedStar Oncology Network - Good Samaritan Hospital — Baltimore, Maryland, United States
• MedStar Oncology Network - Franklin Square — Baltimore, Maryland, United States
• Exeter Hospital — Exeter, New Hampshire, United States
• Staten Island University Hospital — Staten Island, New York, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Parkridge Medical Center — Chattanooga, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Sentara Northern Virginia Medical Center — Woodbridge, Virginia, United States
• Monash Health / Peter MacCallum Cancer Centre — Clayton, Victoria, Australia
• Hospital CUF Porto — Porto, Portugal

Full record on ClinicalTrials.gov

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