Study of Stereotactic Radiotherapy for Breast Cancer

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

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiation SBRT

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jean Wright, MD; Phone Number: 202-537-4787; Email: jwrigh71@jhmi.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital
      • Contact: Victoria Croog, MD; Phone Number: 202-537-4787; Email: vcroog1@jhmi.edu
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Jean Wright, MD
      • Sub-Investigator: Antonio C Wolff, MD
      • Sub-Investigator: Vered Stearns, MD
      • Sub-Investigator: Ben H Park, MD
      • Sub-Investigator: Ashley Cimino, MD
      • Sub-Investigator: Cesar Santa-Maria, MD
      • Sub-Investigator: Susan Harvey, MD
      • Sub-Investigator: Karen Smith, MD
      • Sub-Investigator: Sara Alcorn, MD
      • Sub-Investigator: Arti Parekh, MD
      • Sub-Investigator: Andrea Richardson, MD
      • Sub-Investigator: Pouneh Razavi, MD
      • Sub-Investigator: Xiaoyan Huang, MD
      • Sub-Investigator: Fariba Asrari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT to the breast then surgery; Stereotactic Body Radiation of 21 gy followed by standard of care surgery	Radiation: Stereotactic Body Radiation SBRT; Stereotactic Body Radiation to the breast to 21 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days
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.	90 days
The time to recurrence	To measure local recurrence rate	1 year
Quality of Life	To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)	1 year

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Jean Wright, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimated): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: low risk; early stage
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: J1741; IRB00128074 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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