Status:
WITHDRAWN
An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"
Lead Sponsor:
Xoft, Inc.
Collaborating Sponsors:
Icad, Inc.
Conditions:
Invasive Ductal Carcinoma
Ductal Carcinoma In Situ
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The rationale for IORT as the sole radiation therapy is: Favorable preliminary results in feasibility, safety and efficacy outcomes: Accelerated Partial Breast Irradiation (APBI) is an accepted alter...
Eligibility Criteria
Inclusion
- Subject must have provided written Informed Consent
- Subject must have biopsy-proven ductal carcinoma in situ (DCIS) or invasive ductal carcinoma (IDC) 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
- Clinical staging of 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 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
- Subject is pregnant or nursing
- Subject has active auto-immune disease
- Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
- Subject has multi-focal breast cancer where the sum of the individual tumor sizes (greatest diameters) are \> 3 cm
- 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
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2034
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04349111
Start Date
June 30 2022
End Date
June 30 2034
Last Update
August 2 2022
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