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

Breast Cancer Clinical Trial

— SBRT BREAST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04532177
• Other study ID #: SBU-SBRT-BREAST-NO-SX
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: August 19, 2020
• Est. completion date: August 31, 2027

Study information

• Verified date: October 2023
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy (SBRT)
fractionated linear accelerator based SBRT to 40 Gy in 5 fractions

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of acute and late adverse events grade 3 or greater	Rates of acute and late grade 3 or greater toxicity	5 years
Primary	Partial and complete response rate by clinical and radiographic response		5 years
Secondary	Survival	Progression-free survival and overall survival	5 years