Ablative Pre-operative Radiation for Early Stage Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAsal Rahimi, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Trial Summary

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.

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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

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Treatment Details

Interventions

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

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Single-fraction stereotactic partial breast radiotherapyExperimental Treatment1 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.