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

Stony Brook University

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Breast Cancer

Treatments

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04532177

SBU-SBRT-BREAST-NO-SX

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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