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 now · Not applicable

Conditions studied: Breast Cancer

In brief

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Key facts

Study ID: NCT03643861
Run by: University of Alabama at Birmingham
People needed: 40
Starts: 2019-08-20
Expected to finish: 2028-12-01
Last updated by the study team: 2025-10-31

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC) — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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