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Study of Stereotactic Radiotherapy for Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation SBRT
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring early stage, low risk

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female sex
  • Age > or = to 50 years of age
  • Invasive ductal carcinoma
  • Clinically and radiographically T1 tumor
  • Clinically node negative
  • Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
  • Planning breast conserving surgery including sentinel node biopsy
  • ≥10% expression of ER and/or PR
  • HER2- using the current College of American Pathologists guidelines
  • Post-menopausal
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
  • Pure DCIS without invasive cancer
  • Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
  • Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
  • Positive pregnancy test
  • Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
  • Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
  • Planning mastectomy
  • Unable to tolerate prone positioning

Sites / Locations

  • Sibley Memorial HospitalRecruiting
  • Johns Hopkins HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT to the breast then surgery

Arm Description

Stereotactic Body Radiation of 21 gy followed by standard of care surgery

Outcomes

Primary Outcome Measures

response
To determine the rate of Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)) and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.

Secondary Outcome Measures

The rate of treatment-related toxicity
To determine the rate of severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery.
The rate of cosmetic outcome
To determine the rate of poor cosmetic outcomes from both provider and patient perspectives up to 3 years after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images.
The time to recurrence
To measure local recurrence rate
Quality of Life
To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)

Full Information

First Posted
February 2, 2017
Last Updated
May 30, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT03043794
Brief Title
Study of Stereotactic Radiotherapy for Breast Cancer
Official Title
A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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
Yes

5. Study Description

Brief Summary
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
Detailed Description
This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
early stage, low risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
SBRT to the breast follow by standard of care surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT to the breast then surgery
Arm Type
Experimental
Arm Description
Stereotactic Body Radiation of 21 gy followed by standard of care surgery
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation SBRT
Intervention Description
Stereotactic Body Radiation to the breast to 21 Gy
Primary Outcome Measure Information:
Title
response
Description
To determine the rate of Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)) and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
The rate of treatment-related toxicity
Description
To determine the rate of severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery.
Time Frame
90 days
Title
The rate of cosmetic outcome
Description
To determine the rate of poor cosmetic outcomes from both provider and patient perspectives up to 3 years after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images.
Time Frame
90 days
Title
The time to recurrence
Description
To measure local recurrence rate
Time Frame
1 year
Title
Quality of Life
Description
To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females only
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female sex Age > or = to 50 years of age Invasive ductal carcinoma Clinically and radiographically T1 tumor Clinically node negative Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior) Planning breast conserving surgery including sentinel node biopsy ≥10% expression of ER and/or PR HER2- using the current College of American Pathologists guidelines Post-menopausal Willing and able to provide informed consent Exclusion Criteria: Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma Pure DCIS without invasive cancer Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment Positive pregnancy test Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement. Unable to meet dosimetric constraints due to tumor location and/or patient anatomy Planning mastectomy Unable to tolerate prone positioning
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Wright, MD
Phone
202-537-4787
Email
jwrigh71@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Wright, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Croog, MD
Phone
202-537-4787
Email
vcroog1@jhmi.edu
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Wright, MD
First Name & Middle Initial & Last Name & Degree
Antonio C Wolff, MD
First Name & Middle Initial & Last Name & Degree
Vered Stearns, MD
First Name & Middle Initial & Last Name & Degree
Fariba Asrari, MD
First Name & Middle Initial & Last Name & Degree
Ben H Park, MD
First Name & Middle Initial & Last Name & Degree
Ashley Cimino, MD
First Name & Middle Initial & Last Name & Degree
Cesar Santa-Maria, MD
First Name & Middle Initial & Last Name & Degree
Susan Harvey, MD
First Name & Middle Initial & Last Name & Degree
Karen Smith, MD
First Name & Middle Initial & Last Name & Degree
Sara Alcorn, MD
First Name & Middle Initial & Last Name & Degree
Arti Parekh, MD
First Name & Middle Initial & Last Name & Degree
Andrea Richardson, MD
First Name & Middle Initial & Last Name & Degree
Pouneh Razavi, MD
First Name & Middle Initial & Last Name & Degree
Xiaoyan Huang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Stereotactic Radiotherapy for Breast Cancer

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