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

Early Phase 1

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy (SBRT)

• Registration Number: NCT04532177
• Lead Sponsor: Stony Brook University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-19
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	Stereotactic Body Radiation Therapy (SBRT)	-

Primary Outcome Measures

Name	Time	Method
Partial and complete response rate by clinical and radiographic response	5 years
Rates of acute and late adverse events grade 3 or greater	5 years	Rates of acute and late grade 3 or greater toxicity

Secondary Outcome Measures

Name	Time	Method
Survival	5 years	Progression-free survival and overall survival

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States