Ablative Pre-operative Radiation for Early Stage Breast Cancer

Overseen By Vanessa Igbeka

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Multi-centric disease, Prior RT, Tumor >3cm, Uncontrolled illness, Pregnant/lactating, MRI/CEDM unable, Prior ipsilateral cancer, Tumor <5mm from skin, Lupus/scleroderma

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 tests a new radiation treatment for women with early-stage breast cancer. It seeks to determine the safest radiation dose to shrink the tumor before surgery. Participants should have a single breast tumor that is 3 cm or smaller and has not spread to the skin or lymph nodes. The trial employs advanced technology to precisely target the tumor, minimizing damage to surrounding healthy tissue. Women with estrogen or progesterone receptor-positive tumors who are not pregnant are suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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 single-fraction ablative pre-operative partial breast radiotherapy is safe?

Research has shown that single-session targeted radiation before surgery (S-PBI) is generally safe for patients with early-stage breast cancer. One study found that administering a dose of up to 34Gy in one session was both safe and effective. Another study found this method safe and practical, particularly for older patients with low-risk breast cancer. Many studies have confirmed that targeting only part of the breast with radiation (PBI) is as safe and effective as treating the whole breast. Overall, evidence suggests that this treatment is well-tolerated with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for early-stage breast cancer, which often involve multiple sessions of radiotherapy following surgery, the Single Fraction Ablative Pre-operative Partial Breast Radiation (S-PBI) offers a novel approach. This treatment is unique because it delivers a single, high-dose fraction of radiation directly to the tumor before surgery, using advanced technology like the MR Linac, Gammapod, or Cyberknife systems. Researchers are excited about this approach as it aims to precisely target the tumor with minimal exposure to surrounding tissues, potentially reducing side effects and treatment time significantly. This could provide a more convenient and less invasive option for patients, while maintaining or improving the effectiveness of the treatment.

What evidence suggests that single-fraction ablative pre-operative partial breast radiotherapy could be effective for early stage breast cancer?

Research has shown that a new treatment called single-session targeted radiation before surgery (S-PBI) is promising for early-stage breast cancer. Studies have found that S-PBI, which delivers a high dose of radiation in one session, is safe and effective, particularly for early-stage breast cancer that responds to hormones. This method resembles the traditional approach of treating the whole breast with radiation, especially for women with low-risk breast cancer. Early results suggest that S-PBI before surgery is also a good option for older patients. The treatment uses advanced technology like MR Linac, Gammapod, or Cyberknife to precisely target the tumor, aiming to destroy cancer cells before surgery. ^{1 3 5 6 7}

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 for women over 18 with early-stage breast cancer (tumors up to 3cm, not spread to skin or nodes) who haven't had surgery/chemo for it. They must be estrogen/progesterone receptor positive, Her2neu negative, and able to have an MRI or CEDM. Pregnant/lactating women, those with certain illnesses or a history of breast cancer/radiation are excluded.

Inclusion Criteria

I agree to use birth control during and after the study if I can have children.

I am a woman and at least 18 years old.

My scans show no cancer in the lymph nodes under my arm.

Exclusion Criteria

I do not have any severe illnesses that would stop me from following the study's requirements.

Patients unable to have an MRI or contrast enhanced digital mammography (CEDM)

Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive single-fraction stereotactic partial breast radiotherapy with dose escalation to determine the maximum tolerated dose

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, cosmesis, and treatment response, including acute and late toxicity assessments

5 years

Regular visits (in-person) and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Radiomics on MRI
• Single Fraction Ablative Pre-operative Partial Breast (S-PBI)

Trial Overview The study tests escalating doses of single-fraction preoperative partial breast irradiation (S-PBI), starting at 30Gy in one session and potentially increasing to 34Gy and then 38Gy. It aims to find the highest dose that doesn’t cause unacceptable side effects before surgery.

How Is the Trial Designed?

Group I: Single-fraction stereotactic partial breast radiotherapy Experimental Treatment 1 Intervention

The primary objective is to escalate the dose of 1 fraction stereotactic partial breast radiotherapy utilizing the MR Linac,Gammapod or Cyberknife system to an ablative dose in the pre-operative setting to the primary tumor without exceeding the maximum tolerated dose in patients with early stage breast cancer.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Partial breast irradiation (PBI) is becoming a recognized option for early-stage breast cancer treatment, showing similar local control and safety when used pre-operatively compared to traditional post-operative methods.

Pre-operative accelerated PBI (PAPBI) may offer advantages such as a reduced treatment field, increased eligibility for PBI, and improved breast conservation rates, although long-term data is still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-operative partial breast irradiation: revolutionizing radiation treatment for women with early stage breast cancer. Li, YR., Barry, PN.[2023]

Breast conserving surgery combined with radiation therapy, particularly partial-breast irradiation (PBI) and accelerated partial-breast irradiation (APBI), is gaining acceptance as a viable alternative to mastectomy for early-stage breast cancer, focusing on treating only high-risk areas.

Despite emerging data on the effectiveness of PBI and APBI over 5 to 7 years, key issues such as patient selection, radiation dosing, and overall survival outcomes still need to be addressed through further research and standardized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Workshop on partial breast irradiation: state of the art and the science, Bethesda, MD, December 8-10, 2002. Wallner, P., Arthur, D., Bartelink, H., et al.[2019]

In a phase II trial involving 73 early-stage breast cancer patients, the external beam partial breast irradiation (PBI) regimen of 35 Gy in 7 daily fractions was found to be well-tolerated, with no Grade 3 toxicity reported and only minor side effects observed.

The treatment demonstrated high efficacy, achieving a 98% local control rate and a 96.7% rate of freedom from distant metastases over a median follow-up of 40 months, indicating it is a safe and effective option for patients aged 60 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seven fractions to deliver partial breast irradiation: the toxicity is Low. Trovo, M., Avanzo, M., Vinante, L., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8977020/

Single fraction ablative preoperative radiation treatment for ... Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study – a phase I/II clinical trial protocol

2. sciencedirect.com sciencedirect.com/science/article/pii/S0360301623078306

Early Results of a Phase I Pre-Operative Single Fraction ... First study to show pre-operative SPBI up to 34Gy in a single fraction was safe and effective for early-stage HR+ breast cancer.

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

Preoperative partial breast radiation for favorable early ... Many studies now show comparable efficacy of PBI compared to whole breast irradiation (WBI) for women with low-risk, early-stage breast cancer ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)03488-1/fulltext

Single pre-operative radiation therapy (SPORT-CK) trial for ... Preoperative single-fraction partial breast irradiation is safe and feasible for elderly patients with low-risk breast cancer.

5. abs.amegroups.org abs.amegroups.org/article/view/7064/html

Pre-operative partial breast irradiation: revolutionizing ... Pre-operative partial breast irradiation: revolutionizing radiation treatment for women with early stage breast cancer.

6. redjournal.org redjournal.org/article/S0360-3016(25)00152-X/abstract

Preoperative Single Fraction Stereotactic Partial Breast ... The purpose of this phase 2 clinical study is to investigate the safety and feasibility of a single fraction stereotactic partial breast irradiation (S-PBI) ...

7. tbcr.amegroups.org tbcr.amegroups.org/article/view/99370/html

Preoperative partial breast radiation for favorable early-stage ... Many studies now show comparable efficacy of PBI compared to whole breast irradiation (WBI) for women with low-risk, early-stage breast cancer ...