IORT + CT-Guided Brachytherapy for Breast Cancer

Not currently recruiting at 2 trial locations

Overseen By Steve Fowler

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Shayna Showalter, MD

Disqualifiers: Male, Pregnant, BRCA mutation, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate (during surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering radiation therapy during surgery for individuals with early-stage breast cancer. The aim is to determine if combining intraoperative radiation therapy (IORT) with CT-guided brachytherapy, a targeted form of radiation, is both effective and safe. It targets those who have opted for breast-conserving surgery and have a tumor 3 cm or smaller. This approach may suit women over 45 who have not experienced previous breast cancer on the same side and do not have implants or a BRCA gene mutation. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are undergoing initial medical treatment to reduce tumor size, you may not be eligible for this trial.

What prior data suggests that this method is safe for treating early-stage breast cancer?

Research has shown that using a special type of radiation therapy during surgery is generally safe for treating breast cancer. Studies have found that this approach has few side effects and a low risk of cancer recurrence. Patients report that the treated area looks natural after healing, indicating that it is safe during breast cancer surgery. Overall, these findings suggest that the treatment is well-tolerated and effective for certain patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using IORT with CT-guided HDR brachytherapy for breast cancer because it offers a more precise and targeted approach to radiation treatment. Unlike traditional radiation therapy, which typically requires multiple sessions over several weeks, IORT delivers a concentrated dose of radiation directly to the tumor site during surgery, potentially reducing the overall treatment time. The addition of CT-guided HDR brachytherapy allows for even more precise targeting, which could minimize damage to surrounding healthy tissue and reduce side effects. This combination approach aims to improve patient outcomes by increasing the accuracy and effectiveness of radiation therapy for breast cancer.

What evidence suggests that IORT with CT-Guided HDR Brachytherapy is effective for early-stage breast cancer?

Studies have shown that using IORT (Intraoperative Radiation Therapy) with CT-guided HDR (high-dose-rate) brachytherapy is promising for early-stage breast cancer. Research indicates this method has a low chance of cancer recurrence and few side effects. The trial will evaluate the effectiveness of delivering precise, personalized radiation treatment during surgery using this approach. Initial findings suggest it is safe and effective for carefully selected patients. These results make this treatment an exciting option for managing breast cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Shayna L. Showalter

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for women over 45 with early-stage breast cancer where the tumor is no larger than 3 cm. They must be planning surgery to conserve their breast or remove the whole breast. It's not for those with spread to lymph nodes, prior treatment to shrink the tumor, men, pregnant women, those with implants before radiotherapy, multiple tumors in one breast, skin/chest wall-involved cancer, previous same-side breast cancer or known BRCA mutation.

Inclusion Criteria

I chose a lumpectomy or radiation for my early-stage breast cancer.

I am 45 years old or older.

My tumor is 3 cm or smaller.

Exclusion Criteria

I have a known BRCA gene mutation.

Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).

I have multiple cancer sites in the same breast.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single-fraction intraoperative radiation therapy (IORT) with CT-guided HDR brachytherapy at the time of breast-conserving surgery

Immediate (during surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with efforts to follow patients until death

24 months

What Are the Treatments Tested in This Trial?

Interventions

• IORT with CT-Guided HDR Brachytherapy

Trial Overview

The study tests a new method of delivering radiation therapy called IORT with CT-Guided HDR Brachytherapy during surgery for early-stage breast cancer. The goal is to see if this approach effectively treats cancer at the time of operation.

How Is the Trial Designed?

Group I: IORT with CT-Guided HDR Brachytherapy Experimental Treatment 1 Intervention

Patients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery.

Who Is Running the Clinical Trial?

Shayna Showalter, MD

Lead Sponsor

Trials

3

Recruited

470+

Published Research Related to This Trial

In a study of 23 patients with recurrent cervical cancer, image-guided high-dose rate interstitial brachytherapy (HDR-ISBT) showed a complete response rate of 56.5% and promising post-relapse survival rates, indicating its efficacy as a reirradiation treatment.

While HDR-ISBT is feasible and offers a good chance of survival, 39.1% of patients experienced significant late toxicities, including grade 3 or 4 complications, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided interstitial brachytherapy for recurrent cervical cancer after radiotherapy: A single institution experience. Ren, X., Fu, Y., Liu, Z., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12032993/

Interim Results of a Prospective Phase-II Clinical Trial - PMC

The results from our interim analysis show that PB-IORT is a promising radiation treatment option with a low breast cancer recurrence rate, minimal side effects ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02400658

Efficacy of IORT With CT-Guided HDR Brachytherapy for ...

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery. Detailed ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37870228/

Interim Results of a Prospective Phase-II Clinical Trial - PubMed

Precision breast intraoperative radiation therapy (PB-IORT) is a novel method of IORT that uses customized CT-based treatment plans and high-dose-rate (HDR) ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1526820923003105

Original Article Intraoperative Radiation Therapy Delivered ...

Our initial results indicate that delivering IORT through HDR brachytherapy in carefully selected breast cancer patients is feasible and oncological safe so ...

5.

withpower.com

withpower.com/trial/phase-breast-neoplasms-2-2015-d0528

IORT + CT-Guided Brachytherapy for Breast Cancer

CT-guided high-dose-rate (HDR) brachytherapy has been studied for various cancers, including lung and secondary malignancies, and is generally considered safe.

6.

nature.com

nature.com/articles/s41598-024-73627-x

A systematic review on the techniques, long-term outcomes ...

Abstract. To evaluate the efficacy and safety of four techniques of partial breast irradiation (PBI) including interstitial brachytherapy (ISBT) ...