<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043794</url>
  </required_header>
  <id_info>
    <org_study_id>J1741</org_study_id>
    <secondary_id>IRB00128074</secondary_id>
    <nct_id>NCT03043794</nct_id>
  </id_info>
  <brief_title>Study of Stereotactic Radiotherapy for Breast Cancer</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk&#xD;
      breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm phase II study design, evaluating the pathologic response (primary&#xD;
      endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational&#xD;
      correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to&#xD;
      intact breast tumors in patients with hormone-receptor positive early stage breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>SBRT to the breast follow by standard of care surgery</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response</measure>
    <time_frame>4-6 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of treatment-related toxicity</measure>
    <time_frame>90 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of cosmetic outcome</measure>
    <time_frame>90 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>To measure local recurrence rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>1 year</time_frame>
    <description>To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>SBRT to the breast then surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stereotactic Body Radiation of 21 gy followed by standard of care surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation SBRT</intervention_name>
    <description>Stereotactic Body Radiation to the breast to 21 Gy</description>
    <arm_group_label>SBRT to the breast then surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female sex&#xD;
&#xD;
          -  Age &gt; or = to 50 years of age&#xD;
&#xD;
          -  Invasive ductal carcinoma&#xD;
&#xD;
          -  Clinically and radiographically T1 tumor&#xD;
&#xD;
          -  Clinically node negative&#xD;
&#xD;
          -  Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by&#xD;
             treating physician (MRI may be done after enrollment if not done prior)&#xD;
&#xD;
          -  Planning breast conserving surgery including sentinel node biopsy&#xD;
&#xD;
          -  ≥10% expression of ER and/or PR&#xD;
&#xD;
          -  HER2- using the current College of American Pathologists guidelines&#xD;
&#xD;
          -  Post-menopausal&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus,&#xD;
             rheumatoid arthritis, scleroderma&#xD;
&#xD;
          -  Pure DCIS without invasive cancer&#xD;
&#xD;
          -  Patients who have received or will be receiving neoadjuvant systemic therapy,&#xD;
             endocrine therapy, or targeted agents&#xD;
&#xD;
          -  Breast implant in the involved breast unless the implant will be removed prior to&#xD;
             initiation of study treatment&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Subjects without placement of a biopsy clip at the diagnostic procedure who are&#xD;
             unwilling to undergo clip placement.&#xD;
&#xD;
          -  Unable to meet dosimetric constraints due to tumor location and/or patient anatomy&#xD;
&#xD;
          -  Planning mastectomy&#xD;
&#xD;
          -  Unable to tolerate prone positioning&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>females only</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Wright, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean Wright, MD</last_name>
    <phone>202-537-4787</phone>
    <email>jwrigh71@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sibley Memorial Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria Croog, MD</last_name>
      <phone>202-537-4787</phone>
      <email>vcroog1@jhmi.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Wright, MD</last_name>
    </contact>
    <investigator>
      <last_name>Antonio C Wolff, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vered Stearns, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fariba Asrari, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ben H Park, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ashley Cimino, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cesar Santa-Maria, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Susan Harvey, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karen Smith, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sara Alcorn, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arti Parekh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Richardson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pouneh Razavi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiaoyan Huang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>early stage</keyword>
  <keyword>low risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043794
org study id: J1741
secondary id: IRB00128074
nct id: NCT03043794
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk
      breast cancer.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: SBRT to the breast follow by standard of care surgery
primary purpose: Treatment
masking: None (Open Label)
measure: response
time frame: 4-6 weeks
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.
measure: The rate of treatment-related toxicity
time frame: 90 days
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.
measure: The rate of cosmetic outcome
time frame: 90 days
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.
measure: The time to recurrence
time frame: 1 year
description: To measure local recurrence rate
measure: Quality of Life
time frame: 1 year
description: To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)
arm group label: SBRT to the breast then surgery
arm group type: Experimental
description: Stereotactic Body Radiation of 21 gy followed by standard of care surgery
intervention type: Radiation
intervention name: Stereotactic Body Radiation SBRT
description: Stereotactic Body Radiation to the breast to 21 Gy
arm group label: SBRT to the breast then surgery
criteria: 
gender: Female
gender based: Yes
gender description: females only
minimum age: 50 Years
maximum age: 100 Years
healthy volunteers: No
last name: Jean Wright, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Jean Wright, MD
phone: 202-537-4787
email: jwrigh71@jhmi.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No