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)

Last updated: March 6, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

5 Fraction Stereotactic Body Radiation Therapy

Clinical Study ID

NCT03643861
IRB-300002157
000521633
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) orductal 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 withpathologic margins of at least 2mm.

  • Must be clinically node negative by physical examination. Sentinel node dissectionis not required, but if undertaken, the patient must be pathologically nodenegative.

  • Zubrod Performance Status 0-2.

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: 5 Fraction Stereotactic Body Radiation Therapy
Phase:
Study Start date:
August 20, 2019
Estimated Completion Date:
December 31, 2028

Study Description

This study offers 5 fractions stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 5 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.

Connect with a study center

  • University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

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