<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/NCT01706432</url>
  </required_header>
  <id_info>
    <org_study_id>16802B</org_study_id>
    <secondary_id>NCI-2011-03193</secondary_id>
    <nct_id>NCT01706432</nct_id>
  </id_info>
  <brief_title>Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer</brief_title>
  <official_title>Biologic Endpoints in the Annihilation of Metastases for Oligometastasis (BEAM ON)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies new ways to monitor the impact of hypofractionated image&#xD;
      guided radiation therapy in treating patients with stage IV breast cancer. Radiation therapy&#xD;
      uses high energy x rays to kill tumor cells. Giving radiation therapy in different ways may&#xD;
      kill more tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 15, 2009</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of circulating tumor cells</measure>
    <time_frame>At baseline, 3-4 weeks post-treatment, and every 9-12 weeks for one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of hypofractionated image guided radiotherapy</measure>
    <time_frame>During treatment (about 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with IRDS in tumor sample</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Central Nervous System Metastases</condition>
  <condition>Invasive Ductal Breast Carcinoma</condition>
  <condition>Invasive Ductal Breast Carcinoma With Predominant Intraductal Component</condition>
  <condition>Invasive Lobular Breast Carcinoma</condition>
  <condition>Invasive Lobular Breast Carcinoma With Predominant in Situ Component</condition>
  <condition>Liver Metastases</condition>
  <condition>Lobular Breast Carcinoma in Situ</condition>
  <condition>Lung Metastases</condition>
  <condition>Male Breast Cancer</condition>
  <condition>Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate</condition>
  <condition>Mucinous Ductal Breast Carcinoma</condition>
  <condition>Papillary Ductal Breast Carcinoma</condition>
  <condition>Recurrent Breast Cancer</condition>
  <condition>Stage IV Breast Cancer</condition>
  <condition>Tubular Ductal Breast Carcinoma</condition>
  <condition>Tumors Metastatic to Brain</condition>
  <arm_group>
    <arm_group_label>All participants</arm_group_label>
    <description>Patients will undergo standard of care radiation therapy and have research blood samples collected at following time points:&#xD;
pre-treatment&#xD;
3-4 weeks post-treatment&#xD;
every 9-12 weeks post-treatment for 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>hyperfractionated radiation therapy</intervention_name>
    <description>Undergo hypofractionated radiation therapy</description>
    <arm_group_label>All participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>All participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>stereotactic radiosurgery</intervention_name>
    <description>Undergo stereotactic radiosurgery</description>
    <arm_group_label>All participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving radiation treatment for breast cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically proven diagnosis of breast cancer (invasive ductal,&#xD;
             lobular, medullary, papillary, colloid, tubular)&#xD;
&#xD;
          -  Completion of standard of care treatment for local and regional disease with no known&#xD;
             residual&#xD;
&#xD;
          -  American Joint Committee on Cancer (AJCC) (6th edition, 2002) Stage IV ( Any T, Any N,&#xD;
             M1) based upon the following minimum diagnostic workup:&#xD;
&#xD;
          -  History/physical examination within 8 weeks prior to registration&#xD;
&#xD;
          -  Computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission&#xD;
             tomography (PET) CT of the whole body within 60 days prior to registration&#xD;
&#xD;
          -  MRI of the brain, if clinically indicated&#xD;
&#xD;
          -  Documentation of 1-5 sites of metastatic tumor; each individual site of tumor must be&#xD;
             =&lt; 10 cm or &lt; 500 cc volume and amenable to radiation therapy as seen on standard&#xD;
             imaging (CT, MRI, bone scan)&#xD;
&#xD;
          -  Pathology from at least one metastatic site confirming breast primary is recommended&#xD;
&#xD;
          -  Zubrod performance status =&lt; 2 (Karnofsky &gt;= 60%)&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1,800 cells/mm^3&#xD;
&#xD;
          -  Platelets &gt;= 100,000 cells/mm^3&#xD;
&#xD;
          -  Hemoglobin &gt;= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve&#xD;
             hemoglobin [Hgb] &gt;= 8.0 g/dl is acceptable)&#xD;
&#xD;
          -  Total bilirubin within institutional limits&#xD;
&#xD;
          -  Albumin &gt; 2.9 g/dl&#xD;
&#xD;
          -  Alkaline phosphatase &lt; 2.5x upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &lt; 2.5 x ULN&#xD;
&#xD;
          -  Room air saturation (saturated oxygen [Sa02]) &gt; 90%&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  Patient complete study specific informed consent process and sign consent form prior&#xD;
             to study entry&#xD;
&#xD;
          -  Patients with prior metastatic treatment are eligible if they have been disease free&#xD;
             for &gt; 3 years; participants may receive hormonal and Herceptin treatment at any time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients are ineligible if they have had prior treatment for their metastatic disease&#xD;
             within 3 years&#xD;
&#xD;
          -  Prior radiotherapy that would result in overlap of radiation therapy fields&#xD;
&#xD;
          -  Co-existing or prior invasive malignancy (except non-melanomatous skin cancer) unless&#xD;
             disease free for a minimum of 3 years (for example, carcinoma in situ of the breast,&#xD;
             oral cavity, or cervix are all permissible)&#xD;
&#xD;
          -  Severe, active co-morbidity, defined as follows:&#xD;
&#xD;
          -  Clinically significant pulmonary dysfunction, cardiomyopathy, any history of&#xD;
             clinically significant congestive heart failure (CHF), unstable angina pectoris, or&#xD;
             cardiac arrhythmia&#xD;
&#xD;
          -  Transmural myocardial infarction within the last 6 months&#xD;
&#xD;
          -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time of&#xD;
             registration&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness&#xD;
             requiring hospitalization or precluding study therapy at the time of registration&#xD;
&#xD;
          -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note,&#xD;
             however, that laboratory tests for liver function and coagulation parameters are not&#xD;
             required for entry into this protocol&#xD;
&#xD;
          -  Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease&#xD;
             Control (CDC) definition; note, however, that human immunodeficiency virus (HIV)&#xD;
             testing is not required for entry into this protocol; the need to exclude patients&#xD;
             with AIDS from this protocol is necessary because the treatments involved in this&#xD;
             protocol may be significantly immunosuppressive; protocol-specific requirements may&#xD;
             also exclude immunocompromised patients&#xD;
&#xD;
          -  Pregnancy, breast feeding or women of childbearing potential and men who are sexually&#xD;
             active and not willing/able to use medically acceptable forms of contraception during&#xD;
             treatment and for at least three months following completion; this exclusion is&#xD;
             necessary because the treatment involved in this study may be significantly&#xD;
             teratogenic&#xD;
&#xD;
          -  Prior treatment with anti-angiogenic therapy&#xD;
&#xD;
          -  Significant atelectasis such that CT definition of the gross tumor volume (GTV) is&#xD;
             difficult to determine&#xD;
&#xD;
          -  Exudative, bloody or cytologically malignant effusions&#xD;
&#xD;
          -  Evidence of pleural or pericardial effusion prior to study start; patients with&#xD;
             pleural effusion that is transudative, cytologically negative, and non-bloody are&#xD;
             eligible; if a pleural effusion is too small for diagnostic thoracentesis, the patient&#xD;
             will be eligible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Chmura</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>North Chicago</city>
        <state>Illinois</state>
        <zip>60064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Neoplasms, Second Primary</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Breast Neoplasms, Male</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</mesh_term>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
    <mesh_term>Carcinoma, Lobular</mesh_term>
  </condition_browse>
  <!-- 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/NCT01706432
org study id: 16802B
secondary id: NCI-2011-03193
nct id: NCT01706432
lead sponsor: 
has dmc: No
This pilot clinical trial studies new ways to monitor the impact of hypofractionated image
      guided radiation therapy in treating patients with stage IV breast cancer. Radiation therapy
      uses high energy x rays to kill tumor cells. Giving radiation therapy in different ways may
      kill more tumor cells.
observational model: Case-Only
time perspective: Prospective
measure: Change in the number of circulating tumor cells
time frame: At baseline, 3-4 weeks post-treatment, and every 9-12 weeks for one year
measure: Progression free survival
time frame: 5 years
measure: Overall survival
time frame: 5 years
measure: Side effects of hypofractionated image guided radiotherapy
time frame: During treatment (about 21 days)
measure: Number of patients with IRDS in tumor sample
time frame: Day 1
arm group label: All participants
description: Patients will undergo standard of care radiation therapy and have research blood samples collected at following time points:
pre-treatment
3-4 weeks post-treatment
every 9-12 weeks post-treatment for 1 year
intervention type: Radiation
intervention name: hyperfractionated radiation therapy
description: Undergo hypofractionated radiation therapy
arm group label: All participants
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: All participants
intervention type: Radiation
intervention name: stereotactic radiosurgery
description: Undergo stereotactic radiosurgery
arm group label: All participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Chmura
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Neoplasms, Second Primary
mesh term: Carcinoma in Situ
mesh term: Breast Neoplasms, Male
mesh term: Carcinoma, Ductal, Breast
mesh term: Breast Carcinoma In Situ
mesh term: Carcinoma, Lobular