Clinical trial · Interventional
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
A Safety and 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
NCT01644669CI-TRIAL-00085371active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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
- EXPERIMENTAL
- label
- 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
- Change from baseline reported at 5 years
- description
- IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 5 years.
Secondary outcomes (6)
- measure
- Assess the rate of regional breast tumor recurrence (RBTR)
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 invasive ductal carcinoma or ductal carcinoma in situ 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. 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 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 Exclusion Criteria: 1. Subject is pregnant or nursing 2. Subject has significant auto-immune disease 3. Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer 4. Subject has biopsy-proven multifocal breast cancer 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 13. Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy 14. 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.
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