NCT04349111

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 care, whole breast irradiation (WBI), in women with early stage breast cancer.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
99mo left

Started Jun 2022

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jun 2022Jun 2034

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2034

Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

11.5 years

First QC Date

April 14, 2020

Last Update Submit

July 28, 2022

Conditions

Invasive Ductal CarcinomaDuctal Carcinoma In Situ

Outcome Measures

Primary Outcomes (1)

  • Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years

    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

    Reported at 5 years

Study Arms (1)

Experimental: Intra-operative Radiation Therapy - IORT

OTHER

Intra-operative Radiation Therapy

Radiation: Intra-operative Radiation Therapy - IORT

Interventions

Intra-operative Radiation Therapy - IORTRADIATION

Single dose of 20 Gy

Also known as: Electronic Brachytherapy
Experimental: Intra-operative Radiation Therapy - IORT

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ivanov 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: 20737219BACKGROUND

  • Dickler 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: 19254369BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • A. M. Nisar Syed, MD

    Long Beach Memorial Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single 20Gy dose of electronic brachytherapy (IORT)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

June 30, 2022

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

June 30, 2034

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

No IPD will be shared.