Preoperative Radiation Therapy for Breast Cancer

Overseen By Basak Dogan, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Multi-centric disease, Prior radiation, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new preoperative radiation therapy called PULSAR for women with certain types of early-stage breast cancer. Researchers aim to evaluate the treatment's effectiveness before surgery and explore new imaging techniques to assess the tumor’s response. Women who have not undergone surgery or other treatments for their current breast cancer diagnosis, and whose tumors are 3 cm or smaller, might be suitable candidates for this trial. The goal is to improve treatment options and understand the tumor's response to radiation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in breast cancer therapy.

Do I have to stop taking my current medications for this trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that preoperative partial breast irradiation (PBI) is a promising and safe treatment for early-stage breast cancer. Research indicates that patients usually tolerate these treatments well, with side effects similar to those after surgery. Early results suggest that the treatment effectively targets the tumor while minimizing harm to nearby tissues.

A study is examining the PULSAR method, a type of preoperative radiation therapy, to assess its safety and effectiveness. So far, findings suggest that the side effects are manageable, making it a potentially good option for patients. Overall, evidence indicates that PULSAR is a safe treatment, but ongoing research will provide more detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

PULSAR is unique because it focuses on delivering radiation therapy before surgery, rather than after, which is the standard approach for breast cancer. This preoperative method aims to shrink tumors more effectively, potentially allowing for less invasive surgical procedures. Researchers are excited about PULSAR because it could lead to improved surgical outcomes, reduced side effects, and shorter recovery times for patients.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that PULSAR preoperative radiation is a promising treatment for early-stage breast cancer. Studies have found that administering radiation to part of the breast before surgery can effectively replace the usual post-surgery radiation for some patients. Evidence suggests this method can significantly shrink tumors, with some studies predicting a reduction of more than 20% three months after treatment. PULSAR radiation targets the tumor to shrink it before surgery, potentially improving surgical outcomes and reducing the need for more extensive treatments. Overall, early findings are encouraging for its effectiveness in treating breast cancer. ^{1 5 6 7 8}

Who Is on the Research Team?

Asal Rahimi, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is not specified with detailed eligibility criteria. It appears to be for patients with early-stage ER+ breast cancer, focusing on those who are candidates for pre-operative radiation and non-operative sentinel lymph node biopsy.

Inclusion Criteria

My tumor does not affect the skin above it.

My cancer is located in just one area.

Tumor must be visible on CT scan and/or marked with clip(s) in tumor if not visible

Exclusion Criteria

Patients who are pregnant or lactating

My tumor is larger than 3cm.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gadolinium or other agents used in study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Radiation

Participants receive a single fraction of 30 Gy pre-operative radiation to evaluate efficacy and pathologic complete response rate

9-10 months

Surgery

Surgery is performed for patients with complete imaging response and negative needle biopsy, or postponed for those with residual disease

10-15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Non-operative Sentinel Lymph Node Biopsy
• PULSAR

Trial Overview The study tests the effectiveness of PULSAR preoperative radiation, explores microbubble CEUS as a non-surgical alternative to sentinel lymph node biopsy (SLNBx), and assesses optical angiography (OA) in evaluating treatment response before surgery.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12104959/

Preoperative partial breast radiation for favorable early ... Preoperative PBI is a promising alternative to traditional postoperative radiotherapy for appropriately selected women with early-stage breast cancer.

2. withpower.com withpower.com/trial/phase-2-breast-neoplasms-6-2024-e10fb

Preoperative Radiation Therapy for Breast Cancer Trial Overview The study tests the effectiveness of PULSAR preoperative radiation, explores microbubble CEUS as a non-surgical alternative to sentinel lymph ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2331518025000022

Gradient-Based Radiomics for Outcome Prediction and ... The EFS model shows strong predictive performance in determining whether tumor volume reduction exceeds 20% at the 3-month postradiation time point. Features ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11475788/

Multiomics-Based Outcome Prediction in Personalized ... Stereotactic radiosurgery (SRS) employs highly focused radiation; however, its efficacy decreases with increasing tumor size and carries a ...

5. tbcr.amegroups.org tbcr.amegroups.org/article/download/99370/73523

Peer Review File Article information: https://dx.doi. ... This article summarizes the results of prospective studies (including ongoing ones) of preoperative partial breast radiation therapy for early breast cancer.

6. mdpi.com mdpi.com/2072-6694/16/19/3425

Multiomics-Based Outcome Prediction in Personalized ... This retrospective study aims to develop a multiomics approach that integrates radiomics, dosiomics, and delta features to predict treatment responses in brain ...

7. researchgate.net researchgate.net/publication/391251094_Preoperative_partial_breast_radiation_for_favorable_early-stage_breast_cancer_a_narrative_review

Preoperative partial breast radiation for favorable early- ... Here, we summarize emerging data from prospective studies demonstrating safety and efficacy of preoperative PBI and explore techniques for ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9837822/

Pre-operative partial breast irradiation - PubMed Central - NIH Several early stage studies have more recently shown that PBI can be safely used in the pre-operative setting. Early data show similar local control without ...