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Radiation

Ablative Pre-operative Radiation for Early Stage Breast Cancer

Phase 1

Waitlist Available

Led By Asal Rahimi, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >/= 18 years old and female

Clinically and radiographically node negative on ultrasound of the axilla or MRI

Must not have

Prior ipsilateral breast cancer

Tumor less than 5mm from the skin surface on clinical exam and/or radiographic imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how much radiation a person can handle before it becomes toxic. They will start with a low amount and work their way up to see how high they can go.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include skin changes, fatigue, pain or discomfort in the treated area, swelling or fluid build-up. As this is a dose-escalation study assessing toxicity levels, exact side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman and at least 18 years old.

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

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My tumor does not affect the skin on top of it.

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My cancer is located in one spot only.

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My breast cancer is 3 cm or less and hasn't been treated with surgery or drugs yet.

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My cancer is positive for estrogen or progesterone receptors and negative for HER2.

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My largest tumor is 3cm or smaller, measured before biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had breast cancer in the same breast before.

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My tumor is very close to the skin, less than 5mm away.

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My tumor is larger than 3cm.

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I have had radiation therapy to the breast with cancer.

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I have active Lupus or scleroderma.

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My cancer is present in multiple locations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reach the maximum tolerated dose (MTD)

Secondary study objectives

Acute Toxicity

Cosmesis outcome

Distant Disease-Free Survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 13Eligibility criteria met