One and done? single radiation dose before breast cancer surgery tested
NCT ID NCT04040569
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial is testing whether a single, high dose of radiation given before surgery can safely treat early-stage breast cancer. Researchers are enrolling 45 women with small tumors (3 cm or less) to find the highest dose that does not cause severe side effects. If successful, this approach could shorten treatment from weeks to just one session.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (single-fraction pre-operative partial breast irradiation)
- What this could lead to
- If successful, this could lead to a shorter, more convenient radiation treatment before surgery for early-stage breast cancer, potentially reducing side effects and improving cosmetic outcomes.
- What could go wrong
- This is a very early (Phase I) trial with only 45 participants, so it is primarily testing safety and dosing. The approach may not prove effective or may cause unexpected side effects, and results may not apply to all breast cancer patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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45 people
The number who actually took part.
- Started
-
Dec 2019
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis 2. Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam 3. Age \>/= 18 years old and female 4. Greatest Tumor dimension is 3cm or less based on US. MRI measurements can be included only if performed BEFORE the biopsy 5. Tumor must be unifocal 6. The tumor must be visible on CT scan and/or preferably marked with clip(s) in tumor 7. Patients must undergo an MRI for work up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are present, they need to have a negative biopsy to proceed with treatment.If patient cannot have MRI, contrast enhanced digital mammography (CEDM) is allowed in place of MRI. 8. Clinically and radiographically node negative on ultrasound of the axilla or MRI 9. Estrogen receptor positive or Progesterone receptor positive and Her2neu negative 10. Ability to understand and the willingness to sign a written informed consent. 11. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to the start of study and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months Exclusion Criteria: 1. Multi-centric disease 2. Prior RT to the involved breast 3. Tumor size \>3cm 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements 5. 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 6. Patients unable to have an MRI or contrast enhanced digital mammography (CEDM) 7. Prior ipsilateral breast cancer 8. Tumor less than 5mm from the skin surface on clinical exam and/or radiographic imaging 9. Patients with active Lupus or scleroderma
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
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