Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System® (NCT01644669) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
United States1,200 participantsStarted 2012-05-08
Plain-language summary
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.
Who can participate
Age range40 Years
SexFEMALE
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Inclusion criteria
âś“. Subject must have provided written Informed Consent
âś“. Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
✓. Subject must be female ≥ 40 years of age
âś“. Subject's tumor(s) must be \< 3.0 cm in greatest diameter by pre-operative assessment
âś“. Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (\< 3 cm), N0, M0
Exclusion criteria
âś•. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
âś•. 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
âś•. Subject is pregnant or nursing
âś•. Subject has significant auto-immune disease
âś•. Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
âś•. Subject has biopsy-proven multifocal breast cancer
âś•. Subject has multi-centric breast cancer
What they're measuring
1
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years
Timeframe: Change from baseline reported at 5 years