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NCT Number: NCT04532177

Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

This is a prospective pilot study investigating the safety and efficacy of stereotactic body radiation therapy (SBRT) as a treatment for breast cancer in patients who do not get surgery. The study will accrue 15 patients who will be treated to a dose of 40 Gy over the course of 5 fractions in the Stony Brook University Hospital Department of Radiation Oncology. The subjects will then have a follow up time of 5 years.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >/= 18
  • Biopsy proven invasive carcinoma of the breast
  • Clinical T1-T4 invasive carcinoma
  • Cancer is deemed unresectable with no possibility of future resection or the patient is a poor surgical candidate as determined following evaluation by a surgeon.
  • Women who are not post-menopausal should have a negative urine or serum pregnancy test. Women of childbearing potential must agree to adequate contraception for the duration of study participation.
  • Ability to understand and willingness to sign a written informed consent document
  • Life expectancy > 6 months
  • Patient is to be treated at Stony Brook University Hospital

Exclusion criteria

  • Women with a known pregnancy, positive serum pregnancy test, or currently breastfeeding as well as women of childbearing potential unwilling or unable to use an acceptable method of birth control (including abstinence or barrier method of birth control) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Breast implant in the breast to be treated with SBRT
  • Insufficient breast imaging to judge clinical stage
  • Inability to receive study treatment planning and treatment secondary to body habitus
  • Inability to understand or unwillingness to sign a written consent document
  • Life expectancy < 6 months
  • Children (< 18 years of age)
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with study requirements

Treatment and study plan

Stereotactic Body Radiation Therapy (SBRT)

Radiation

fractionated linear accelerator based SBRT to 40 Gy in 5 fractions

Primary outcomes

  1. Rates of acute and late adverse events grade 3 or greater

    Time frame: 5 years

    Rates of acute and late grade 3 or greater toxicity

  2. Partial and complete response rate by clinical and radiographic response

    Time frame: 5 years

Secondary outcomes

  1. Survival

    Time frame: 5 years

    Progression-free survival and overall survival

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

Acronym: SBRT BREAST

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2020
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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