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

Primary Purpose

Breast Cancer

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stony Brook University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

Outcomes

Primary Outcome Measures

Rates of acute and late adverse events grade 3 or greater
Rates of acute and late grade 3 or greater toxicity
Partial and complete response rate by clinical and radiographic response

Secondary Outcome Measures

Survival
Progression-free survival and overall survival

Full Information

First Posted
August 25, 2020
Last Updated
October 16, 2023
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT04532177
Brief Title
Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Acronym
SBRT BREAST
Official Title
Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Intervention Description
fractionated linear accelerator based SBRT to 40 Gy in 5 fractions
Primary Outcome Measure Information:
Title
Rates of acute and late adverse events grade 3 or greater
Description
Rates of acute and late grade 3 or greater toxicity
Time Frame
5 years
Title
Partial and complete response rate by clinical and radiographic response
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Survival
Description
Progression-free survival and overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander M Stessin, MD
Organizational Affiliation
Stony Brook Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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