IORT with Xoft Axxent System for Breast Cancer

Overseen By Maen Farha, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: MedStar Franklin Square Medical Center

Disqualifiers: Pregnancy, Auto-immune disease, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breast cancer treatment method called intra-operative radiation therapy (IORT) using the Xoft Axxent Electronic Brachytherapy System. It targets women with early-stage breast cancer, specifically those with types such as ductal carcinoma in situ or invasive ductal carcinoma. The trial aims to determine if this treatment can effectively prevent cancer recurrence in the same breast, compared to the usual whole breast irradiation, over five years. Women with a single breast tumor smaller than 3 cm, who have not undergone certain prior treatments or have specific conditions, are suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in breast cancer therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Xoft Axxent Electronic Brachytherapy System is safe for intra-operative radiation therapy?

Research has shown that the Xoft Axxent Electronic Brachytherapy System is safe for treating early-stage breast cancer. In one study, patients handled the treatment well, with no major safety problems. Another study found that the treatment did not cause cancer cells to grow, indicating it is safe to use during surgery. Additionally, a long-term study, with an average follow-up of about 4.5 years, showed low rates of cancer recurrence, supporting its safety and effectiveness. Overall, these findings suggest that the Xoft Axxent System is a safe choice for radiation therapy during surgery. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

The Xoft Axxent Electronic Brachytherapy System is unique because it offers a new way to deliver radiation therapy directly to the site of a tumor during surgery, known as Intra-Operative Radiation Therapy (IORT). Unlike traditional radiation treatments for breast cancer, which often require multiple sessions over several weeks, this system provides a single, targeted dose of radiation to the affected area immediately after tumor removal. Researchers are excited about this method because it has the potential to reduce overall treatment time and minimize radiation exposure to healthy surrounding tissues, potentially leading to fewer side effects and quicker recovery for patients.

What evidence suggests that the Xoft Axxent System is effective for early stage breast cancer?

Research has shown that the Xoft Axxent Electronic Brachytherapy System, used as intra-operative radiation therapy (IORT) during a lumpectomy, effectively treats early-stage breast cancer. Studies have found that this treatment offers promising results. In a long-term study, the Xoft System successfully lowered the risk of cancer returning in the same breast, with results similar to other IORT methods. This system delivers precise and focused radiation, reducing the need for extensive radiation therapy. Overall, the Xoft System provides a reliable option for those undergoing breast cancer surgery. ^{5 6 7 8 9}

Who Is on the Research Team?

Maen Farha, MD

Principal Investigator

Medstar Health Research Institute

Are You a Good Fit for This Trial?

This trial is for women over 40 with early-stage breast cancer, where the tumor is less than 3cm and hasn't spread. It's open to those who haven't had recurrent breast cancer or certain genetic mutations, aren't pregnant or nursing, don’t have significant autoimmune diseases or a pacemaker in the radiation field, and haven’t received prior treatments that could affect the study.

Inclusion Criteria

Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment

Subject must have provided written Informed Consent

I agree to use effective birth control during and after my treatment.

Exclusion Criteria

I cannot undergo radiation therapy due to health risks.

My cancer has spread to my lymph or blood vessels.

I have a BRCA 1 or 2 mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intra-Operative Radiation Therapy

Participants receive single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for ipsilateral breast tumor recurrence and other outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Xoft Axxent Electronic Brachytherapy System

Trial Overview The study tests intra-operative radiation therapy (IORT) using Xoft Axxent eBx System during lumpectomy in patients with early-stage breast cancer. The goal is to compare this single treatment's effectiveness against traditional whole breast irradiation after five years.

How Is the Trial Designed?

Group I: XOFT-Intra-Operative Radiation Therapy Experimental Treatment 1 Intervention

XOFT-Intra-Operative Radiation Therapy

Who Is Running the Clinical Trial?

MedStar Franklin Square Medical Center

Lead Sponsor

Trials

2

Recruited

110+

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01644669

Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01644669?tab=history&a=23

Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT ... 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.

3. icadmed.com icadmed.com/about/news-events/press-releases/independent-long-term-study-highlights-effectiveness-of-icads-xoft-electronic-brachytherapy-system-for-early-stage-breast-cancer-treatment/

Independent, Long-Term Study Highlights Effectiveness of ... “The compelling findings, comparable to other IORT methods previously examined, show IORT with the Xoft System is successful in delivering ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8534590/

Intraoperative Radiotherapy with Balloon-Based Electronic ... Long-term results from this trial are published in 2021 with a median follow-up of 12.4 years and confirm the higher RR in the IOERT group, ...

5. elekta.com elekta.com/products/brachytherapy/xoft/

Elekta Xoft | Brachytherapy Elekta Xoft empowers you to treat cancer precisely and effectively in any clinical setting. Requiring no bunker or dedicated shielding, and with its compact ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01644669

Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System 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 ...

7. clinicaltrial.be clinicaltrial.be/en/details/12693?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT... An in vitro study showed that un-irradiated wound fluid stimulated the growth of breast cancer cells while irradiated wound fluid did not. Each ...

8. elekta.com elekta.com/products/brachytherapy/xoft/clinical-resources/

Clinical Resources | Xoft “Twelve-Month Follow-Up Results of a Trial Utilizing Axxent Electronic Brachytherapy to Deliver Intraoperative Radiation Therapy for Early-Stage Breast Cancer.” ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5667880/

Multi-center study on patient selection for and the ... Another single-institution trial also found that delivery of IORT via the eBX system was efficacious and safe for women with early-stage breast ...