Recruiting

Partial Breast Irradiation

Sponsor:

University of Alabama at Birmingham

Code:

NCT03643861

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

5 Fraction Stereotactic Body Radiation Therapy

Study Details

Brief summary:

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

Conditions

Breast Cancer

Study ID

NCT03643861

Start date

Aug 20, 2019

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 5 Fraction Breast Stereotactic Body Radiation Therapy

This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fractions stereotactic body radiation therapy at a dose of 6 gy for 5 fractions for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months.

Interventions

5 Fraction Stereotactic Body Radiation Therapy

Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physician and physicist oversight for all treatments. While more labor intensive and often utilizing more advanced technologies, SBRT allows the advantage of reducing setup margins compared to conventionally fractionated treatment while being able to shorten overall treatment times due to the ability to safely dose escalate high risk areas

Primary outcome measure

  • Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0 [ Time Frame: 0-2 years ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Birmingham, Alabama, United States, 35233

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • SBRT
  • Breast cancer
  • Early stage
  • Radiation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-10-31.