IOeRT for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Avera McKennan Hospital & University Health Center

Disqualifiers: Prior malignancy, Immuno-compromised, Pregnancy, 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 explores a new approach to treat breast cancer by combining surgery with a single dose of radiation, known as Intraoperative Electron Radiation Therapy (IOeRT), to determine its effectiveness in preventing cancer recurrence. The trial aims to assess whether this method works as well as traditional treatments and if it results in fewer side effects or a better cosmetic outcome. Women who have gone through menopause and have certain types of early-stage breast cancer without genetic risks, such as BRCA mutations, might be suitable candidates. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future breast cancer treatments.

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 this method is safe for breast cancer treatment?

Research shows that Intraoperative Electron Radiation Therapy (IOeRT) is generally well-tolerated for treating breast cancer. Studies indicate that IOeRT prevents cancer recurrence in the treated area in over 90% of cases, even for high-risk patients.

Regarding safety, IOeRT achieves similar or better outcomes compared to traditional radiation treatments. It often results in a more natural appearance of the breast after treatment and is considered cost-effective.

Although researchers continue to study IOeRT, it has demonstrated promising safety and effectiveness. Its use in regular medical practice for qualifying patients indicates confidence in its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for breast cancer, which often involve multiple sessions of radiation therapy over several weeks, Single Fraction IOeRT offers a unique approach by delivering a high dose of radiation in just one session. This method is exciting because it targets the tumor bed directly during surgery and minimizes exposure to surrounding healthy tissues. Researchers are particularly interested in IOeRT because it could potentially reduce treatment time and enhance patient convenience without compromising effectiveness.

What evidence suggests that Single Fraction IOeRT is effective for breast cancer?

Research has shown that Intraoperative Electron Radiation Therapy (IOeRT), administered as a single fraction in this trial, can effectively treat breast cancer. Studies have found that even in challenging cases, such as triple-negative breast cancer, IOeRT prevents cancer recurrence in the treated area over 90% of the time. For most patients, this means the cancer does not return where it was treated. Additionally, IOeRT is considered safe and may offer better cosmetic results compared to traditional whole breast radiotherapy. These findings suggest that IOeRT is a promising option for controlling cancer while potentially reducing side effects. ^{1 3 6 7 8}

Who Is on the Research Team?

Kyle Arneson

Principal Investigator

Avera Cancer Insitute

Are You a Good Fit for This Trial?

This trial is for post-menopausal women over 60 with a specific type of early-stage breast cancer that hasn't spread to lymph nodes. Candidates must have negative surgical margins, be BRCA1/2 negative, and agree to breast conservation therapy and sentinel lymph node biopsy. They should not have received prior chemotherapy for this cancer or have certain aggressive cancer features.

Inclusion Criteria

My breast cancer is a single, small tumor less than 2cm.

The edges of the removed tissue show no signs of cancer under a microscope.

I agree to have a sentinel lymph node biopsy to check my underarm area.

Exclusion Criteria

My immune system is weakened.

I have had breast cancer or another cancer that has not spread and is not expected to shorten my life within 5 years.

My breast cancer has spread to my skin or chest wall.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Radiation

Participants undergo lumpectomy and receive a single dose of Intraoperative Electron Radiation Therapy (IOeRT)

1 day

1 visit (in-person)

Post-Surgery Consultation

Participants meet with a medical oncologist to discuss chemotherapy and/or hormone therapy if indicated

1-2 weeks

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

10 years

Regular visits with surgeon, radiation oncologist, and research staff

What Are the Treatments Tested in This Trial?

Interventions

• Single Fraction IOeRT

Trial Overview The study tests if a single dose of Intraoperative Electron Radiation Therapy (IOeRT) after lumpectomy can prevent the recurrence of local breast cancer effectively while maintaining cosmetic appearance and minimizing side effects compared to traditional treatments.

How Is the Trial Designed?

Group I: Single Fraction IOeRT Experimental Treatment 1 Intervention

A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Who Is Running the Clinical Trial?

Avera McKennan Hospital & University Health Center

Lead Sponsor

Trials

35

Recruited

29,200+

Published Research Related to This Trial

Intraoperative radiotherapy (IORT) is an emerging treatment option for early-stage breast cancer that aims to reduce the volume of treatment, minimize toxicity, and shorten treatment duration after breast-conserving surgery.

The implementation of IORT in community cancer centers involves various challenges, including licensing, staffing, technical support, and reimbursement, which need to be addressed for successful adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy for breast cancer: its perceived simplicity. Ash, RB., Williams, VL., Wagman, LD., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6062668/

Intraoperative Electron Radiotherapy (IOERT) in the Treatment ... Even in high-risk groups like triple-negative or locally advanced breast cancers, IOERT contributes to long-term local control rates of more than 90%. For ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301607002544

Single-Fraction Intraoperative Radiotherapy for Breast ... The results of our study have shown that IORT delivered in a single fraction at definitive breast-conserving surgery is feasible and leads to acceptable ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1411598/full

Comparative long-term oncological outcomes of ... At a median follow-up of 64.6 months, IORT demonstrated 11 locoregional recurrences (LRR), 1 metastasis, and 1 death, compared to 4 LRR, 5 ...

4. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.15092

Long‑term follow‑up outcomes of intraoperative ... IORT offers comparable safety, improved cosmesis and greater cost‐effectiveness than PORT, supporting its integration into clinical practice for eligible ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-022-10468-9

Postoperative cosmetic outcome of intraoperative ... In this study, we aim to evaluate the cosmetic outcome differences between Intraoperative electron beam radiation therapy (IOERT) and whole breast radiotherapy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493767/

Comparative long-term oncological outcomes of ... At a median follow-up of 64.6 months, IORT demonstrated 11 locoregional recurrences (LRR), 1 metastasis, and 1 death, compared to 4 LRR, 5 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468294225000620

Long-term oncologic outcome of intraoperative ... We confirmed the oncologic safety of IORT with low-energy X-rays as a tumor-bed boost in Korean patients with breast cancer through a long-term follow-up period ...

8. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.850351/full

Long-Term Outcomes of an International Cooperative ... Recent data have suggested an improvement in breast cancer mortality for those patients undergoing IORT; nevertheless, different confusing factors might be ...