Trial Summary
What is the purpose of this trial?
This trial is testing a device that gives a single dose of radiation during breast cancer surgery. It targets women with early-stage breast cancer to see if it works as well as the usual longer radiation treatments. The goal is to make treatment quicker and easier while still being effective.
Research Team
AN
A.M. Nisar Syed, MD
Principal Investigator
Long Beach Memorial Medical Center
Eligibility Criteria
This trial is for women over 40 with early-stage breast cancer (ductal carcinoma) that's less than 3 cm in size. They must not be pregnant or nursing, agree to use birth control, and have no history of certain breast cancers or treatments like chemotherapy before surgery. Women with pacemakers near the treatment area or autoimmune diseases can't join.Inclusion Criteria
I have been diagnosed with a type of breast cancer.
My cancer is early stage and the tumor is small.
Both of my breast cancers qualify for the trial based on all required conditions.
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Exclusion Criteria
I have received initial treatment with chemotherapy or hormone therapy for my current breast cancer.
I am at high risk for breast-saving surgery or radiation during surgery.
My cancer has spread to my lymph system or blood vessels.
See 11 more
Treatment Details
Interventions
- Xoft® Axxent® eBx® IORT System® (Brachytherapy)
Trial OverviewThe study tests the Xoft Axxent eBx System for single-fraction IORT as a stand-alone radiation therapy compared to whole breast irradiation in treating early stage breast cancer during conserving therapy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Intra-operative Radiation Therapy - IORTExperimental Treatment1 Intervention
Intra-operative Radiation Therapy
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Who Is Running the Clinical Trial?
Xoft, Inc.
Lead Sponsor
Trials
11
Recruited
2,200+
Icad, Inc.
Industry Sponsor
Trials
5
Recruited
1,300+
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