Intra-operative Radiation Therapy for Breast Cancer

Recruiting at 27 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Xoft, Inc.

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: 7

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy during surgery for women with early-stage breast cancer. The aim is to determine if this method, called intra-operative radiation therapy (IORT), is as safe and effective as the standard approach, which treats the whole breast after surgery. The trial uses the Xoft® Axxent® eBx® IORT System®, a specific system for delivering IORT. Women eligible for this trial have a tumor smaller than 3 cm, confirmed ductal carcinoma (a type of breast cancer), and no history of conditions such as multifocal or lobular cancer. This trial may offer an alternative to traditional radiation therapy. As an unphased trial, it provides patients the chance to explore innovative treatment options that could potentially enhance their quality of life.

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 eBx System is safe for intra-operative radiation therapy in early stage breast cancer?

Research has shown that the Xoft Axxent eBx IORT System is safe for patients. This system delivers a focused dose of radiation during surgery and is well-tolerated by women with early-stage breast cancer.

In one study, patients who received this treatment experienced minimal side effects, indicating its safety. Another review of trials using this system found that both short-term and long-term effects were manageable, with no major adverse events reported.

Overall, early findings suggest that the Xoft Axxent eBx IORT System provides a safe and effective method for delivering radiation therapy during breast cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Xoft® Axxent® eBx® IORT System® because it offers a unique approach to treating breast cancer. Unlike traditional radiation therapy, which is typically administered externally over several weeks, this system delivers radiation directly to the tumor site during surgery. This intra-operative method targets cancer cells more precisely, potentially reducing exposure to surrounding healthy tissue and shortening overall treatment time. By integrating radiation directly into the surgical process, it aims to improve convenience and outcomes for patients.

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

Research has shown that the Xoft Axxent eBx IORT System, which participants in this trial will receive, effectively treats early-stage breast cancer. Studies have found that this system delivers focused radiation during surgery, leading to good cosmetic outcomes and a low risk of recurrence. A review of European studies highlighted that patients found this treatment convenient and were pleased with the results. Another study confirmed that the system is safe and effective for women with early-stage breast cancer. Overall, the evidence supports its potential as a good treatment option. ^{2 3 4 6 7}

Who Is on the Research Team?

A.M. Nisar Syed, MD

Principal Investigator

Long Beach Memorial Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intra-operative Radiation Therapy (IORT)

Participants receive single-fraction IORT using the Xoft Axxent eBx System during breast conserving surgery

1 day

1 visit (in-person, during surgery)

Follow-up

Participants are monitored for safety, efficacy, and recurrence of breast cancer

10 years

Visits at Month 6, Month 12, Month 18, Year 2, and annually through Year 10

What Are the Treatments Tested in This Trial?

Interventions

• Xoft® Axxent® eBx® IORT System®

Trial Overview The 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.

How Is the Trial Designed?

Group I: Intra-operative Radiation Therapy - IORT Experimental Treatment 1 Intervention

Intra-operative Radiation Therapy

Who Is Running the Clinical Trial?

Xoft, Inc.

Lead Sponsor

Trials

11

Recruited

2,200+

Icad, Inc.

Industry Sponsor

Trials

5

Recruited

1,300+

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

Intraoperative Radiotherapy with Balloon-Based Electronic ... This is a systematic review of all trials investigating the feasibility, short, and long-term effects of IORT performed with Axxent® eBx (iCAD, ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)30398-9/fulltext

Intraoperative radiotherapy with electronic brachytherapy ... Conclusions: The European studies using the Axxent® eBx®system for IORT show excellent cosmetic results, low recurrence rate and convenience for both patients ...

4. elekta.com elekta.com/products/brachytherapy/xoft/

Elekta Xoft | Brachytherapy Elekta Xoft delivers low energy, high dose rate localized radiation therapy using a 50 kV miniaturized X-ray source. The system's low energy design allows it to ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0185876

Multi-center study on patient selection for and the oncologic ... Another single-institution trial also found that delivery of IORT via the eBX system was efficacious and safe for women with early-stage breast cancer [11]. The ...

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... Favorable preliminary results in feasibility, safety and efficacy outcomes: Accelerated Partial Breast Irradiation (APBI) is an accepted ...