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

45 Participants Needed

Trial Summary

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 Ablative Pre-operative Radiation for Early Stage Breast Cancer?

Early studies suggest that pre-operative partial breast irradiation (PBI) can be safely used for early-stage breast cancer, showing similar local control and no increased side effects compared to traditional methods. This approach may also improve breast conservation rates and treatment compliance. ^{1 2 3 4 5}

Is pre-operative partial breast irradiation safe for early-stage breast cancer?

Early studies suggest that pre-operative partial breast irradiation (PBI) is generally safe for early-stage breast cancer, with no increased toxicity or worsening of cosmetic outcomes compared to other radiation methods. However, long-term safety data is still being collected. ^{3 6 7 8 9}

How is the Single Fraction Ablative Pre-operative Partial Breast Irradiation (S-PBI) treatment different from other treatments for early-stage breast cancer?

The Single Fraction Ablative Pre-operative Partial Breast Irradiation (S-PBI) is unique because it delivers a high dose of radiation in a single session before surgery, targeting only the part of the breast at high risk for cancer recurrence, unlike traditional treatments that involve multiple sessions of whole breast radiation after surgery. ^{1 2 4 10 11}

What is the purpose of this trial?

The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.

Research Team

Asal Rahimi, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Preoperative robotic radiosurgery for early breast cancer: Results of the phase II ROCK trial (NCT03520894). [2022]

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

Workshop on partial breast irradiation: state of the art and the science, Bethesda, MD, December 8-10, 2002. [2019]

3. China pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Partial breast radiation for early-stage breast cancer. [2012]

5. Ireland pubmed.ncbi.nlm.nih.gov

Has partial breast irradiation by IORT or brachytherapy been prematurely introduced into the clinic? [2012]

6. Ireland pubmed.ncbi.nlm.nih.gov

First results of the preoperative accelerated partial breast irradiation (PAPBI) trial. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Toxicity and cosmesis following partial breast irradiation consisting of 40 Gy in 10 daily fractions. [2018]

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

Hypofractionated whole breast radiation and partial breast radiation for early-stage breast cancers: an update on progress. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Seven fractions to deliver partial breast irradiation: the toxicity is Low. [2018]

10. Ireland pubmed.ncbi.nlm.nih.gov

A treatment planning study comparing whole breast radiation therapy against conformal, IMRT and tomotherapy for accelerated partial breast irradiation. [2007]

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

Preliminary Results of Multi-Institutional Phase 1 Dose Escalation Trial Using Single-Fraction Stereotactic Partial Breast Irradiation for Early Stage Breast Cancer. [2022]