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RAD 1802: Stereotactic Body Radiotherapy for Early Stage Breast Cancer

This study is testing a new way to deliver radiation therapy called 5 Fraction Stereotactic Body Radiation Therapy (SBRT) for early-stage breast cancer. This treatment involves only 5 doses of radiation after you've had a lumpectomy. The study wants to see if this shorter treatment is safe and works as well as the longer radiation treatments currently used. You might be able to join if you are over 50, have early-stage breast cancer (invasive mammary carcinoma or DCIS) with a tumor size under 2.0cm (or 2.5cm for pure DCIS), and your cancer is Estrogen receptor (ER) positive (>10%). The study will consider this treatment successful if it shows acceptable levels of side effects. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is testing a specific radiation treatment.
What's involved
You would receive 5 fractions of stereotactic body radiation therapy. You would also have follow-up appointments at 6, 12, 18, 24, and 36 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 36 months (3 years) after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03643861

RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Recruiting
NAAges 18–99InterventionalTreatment
University of Alabama at Birmingham
~40 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:5 Fraction Stereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0
Measured over 0-2 years

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaESR1 Gene

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • D. Hunter Boggs, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

D. Hunter Boggs, MD
[email protected]
(205) 934-5670
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
Age\>50.
Maximum pathologic tumor size \<2.0cm if invasive carcinoma or \< 2.5cm if pure DCIS.
Estrogen receptor (ER) positive (\>10%).
Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
Zubrod Performance Status 0-2.

Exclusion

Multifocal or multicentric cancer.
Reception of neoadjuvant chemotherapy.
Pure invasive lobular histology.
Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
Measured maximum PTV of \>124cc.
Lumpectomy cavity within 5mm of body contour.

What this trial measures

  • Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.00-2 years

    To determine the safety of 5 fractions SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.