Clinical trial · Interventional
An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"
An Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent eBx System at the Time of Breast Conservation Surgery for Early Stage Breast Cancer "Lite"
NCT04349111CI-TRIAL-00060012withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of site participation
Summary
Brief summary (as posted)
The purpose of this trial is to assess the efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. A comparison will be made to the current standard of care, whole breast irradiation (WBI), in women with early stage breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Ductal Carcinoma | Invasive Breast Carcinoma of No Special Type | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative Radiation Therapy - IORT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Experimental: Intra-operative Radiation Therapy - IORT
- description
- Intra-operative Radiation Therapy
- interventionNames
- Radiation: Intra-operative Radiation Therapy - IORT
Primary outcomes (1)
- measure
- Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years
- timeFrame
- Reported at 5 years
- description
- To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to whole breast irradiation (WBI) at 5 years of follow-up
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject must have provided written Informed Consent 2. Subject must have biopsy-proven ductal carcinoma in situ (DCIS) or invasive ductal carcinoma (IDC) of the breast 3. Subject must be female ≥ 40 years of age 4. Subject's tumor(s) must be \< 3.0 cm in greatest diameter by pre-operative assessment 5. Clinical staging of Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (\< 3 cm), N0, M0 6. Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria 7. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment 8. Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as 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 Exclusion Criteria: 1. Subject is pregnant or nursing 2. Subject has active auto-immune disease 3. Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer 4. Subject has multi-focal breast cancer where the sum of the individual tumor sizes (greatest diameters) are \> 3 cm 5. Subject has multi-centric breast cancer 6. Subject has known lympho-vascular invasion 7. Subject has invasive lobular cancer 8. Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer 9. Subject has a history of recurrent breast cancer in the ipsilateral breast 10. Subject has had previous radiation exposure of the involved breast 11. 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 12. Subject has contraindications for radiation
References
Publications (2)
- BACKGROUNDIvanov O, Dickler A, Lum BY, Pellicane JV, Francescatti DS. Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. Ann Surg Oncol. 2011 Feb;18(2):453-8. doi: 10.1245/s10434-010-1283-x. Epub 2010 Aug 25. PMID 20737219
- BACKGROUNDDickler A, Ivanov O, Francescatti D. Intraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapy. World J Surg Oncol. 2009 Mar 2;7:24. doi: 10.1186/1477-7819-7-24. PMID 19254369