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

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.

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 data supports the effectiveness of the treatment Xoft® Axxent® eBx® IORT System® for breast cancer?

The Xoft Axxent® eBx® system is shown to be a safe and feasible option for delivering radiation during surgery for early-stage breast cancer, with studies reporting low recurrence rates (1-5.8%) and excellent cosmetic outcomes. However, there are no randomized controlled trials yet to confirm its long-term effectiveness. ^{1 2 3 4 5}

Is intra-operative radiation therapy using the Xoft Axxent® eBx® IORT System® safe for humans?

Current evidence suggests that the Xoft Axxent® eBx® system is generally safe for delivering intra-operative radiation therapy in early-stage breast cancer patients, with studies reporting excellent cosmetic outcomes and low recurrence rates. However, there is limited data on long-term safety, and no randomized controlled trials have been conducted to confirm its long-term effectiveness. ^{1 2 3 4 6}

How is the Xoft Axxent eBx IORT System treatment different from other breast cancer treatments?

The Xoft Axxent eBx IORT System is unique because it delivers radiation directly to the tumor area during surgery, which can reduce the need for multiple radiation sessions after surgery. This approach targets the cancer more precisely and may minimize exposure to surrounding healthy tissue compared to traditional whole breast radiation therapy. ^{1 2 3 5 7}

Research Team

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Multi-center study on patient selection for and the oncologic safety of intraoperative radiotherapy (IORT) with the Xoft Axxent® eBx® System for the management of early stage breast cancer in Taiwan. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Radiation Using Low-Kilovoltage X-Rays for Early Breast Cancer: A Single Site Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Acute and Chronic Complications in Breast Cancer Patients Treated with Intraoperative Radiation Therapy. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intraoperative Radiotherapy with Balloon-Based Electronic Brachytherapy System-A Systematic Review and First Bulgarian Experience in Breast Cancer Patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Single institute experience of intraoperative radiation therapy in early-stage breast cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy (IORT) for breast cancer using the Intrabeam system. [2022]