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 States, Australia, Portugal1,200 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 range
40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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