<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/NCT02186470</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-13282</org_study_id>
    <secondary_id>NCI-2014-01248</secondary_id>
    <nct_id>NCT02186470</nct_id>
  </id_info>
  <brief_title>Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer</brief_title>
  <official_title>Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation&#xD;
      (APBI) before surgery in treating older patients with estrogen receptor positive or&#xD;
      progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation&#xD;
      therapy that delivers a high dose of radiation directly to the tumor may kill more tumor&#xD;
      cells and cause less damage to normal tissue. Giving radiation therapy before surgery may&#xD;
      make the tumor smaller and reduce the amount of normal tissue that needs to be removed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      Establish the feasibility for preoperative APBI delivered with IMRT in the prone position&#xD;
      using daily CT guidance for Stage I breast cancer patients who are intended to undergo a&#xD;
      lumpectomy for breast conserving therapy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
        1. To determine the acute and late surgical and radiation toxicity of preoperative APBI&#xD;
           delivered with IMRT in the prone position.&#xD;
&#xD;
        2. To document the cosmetic appearance of the breast when treated with preoperative APBI&#xD;
           IMRT in the prone position.&#xD;
&#xD;
        3. Establish the percentage of patients that can meet dosimetric goals and normal tissue&#xD;
           constraints if treated with preoperative APBI IMRT in the prone position.&#xD;
&#xD;
        4. Evaluate molecular changes in breast cancer and/or stroma before and after preoperative&#xD;
           APBI&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone&#xD;
      position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI,&#xD;
      patients undergo lumpectomy.&#xD;
&#xD;
      After completion of treatment, patients are followed up at 4 weeks and then every 6 months&#xD;
      for 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 29, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method</measure>
    <time_frame>4-6 weeks post-APBI</time_frame>
    <description>Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0</measure>
    <time_frame>Up to 4 weeks post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic outcome by the physician and patient</measure>
    <time_frame>At year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic outcome by the physician and patient</measure>
    <time_frame>At year 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-breast recurrence</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional recurrence</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastases</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs</measure>
    <time_frame>Up to 4 weeks post-surgery</time_frame>
    <description>Correlative analyses</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Estrogen Receptor-positive Breast Cancer</condition>
  <condition>Invasive Ductal Breast Carcinoma</condition>
  <condition>Invasive Ductal Breast Carcinoma With Predominant Intraductal Component</condition>
  <condition>Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate</condition>
  <condition>Mucinous Ductal Breast Carcinoma</condition>
  <condition>Papillary Ductal Breast Carcinoma</condition>
  <condition>Progesterone Receptor-positive Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Tubular Ductal Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Treatment (image-guided intensity-modulated APBI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>accelerated partial breast irradiation</intervention_name>
    <description>Undergo image-guided intensity-modulated APBI</description>
    <arm_group_label>Treatment (image-guided intensity-modulated APBI)</arm_group_label>
    <other_name>APBI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>intensity-modulated radiation therapy</intervention_name>
    <description>Undergo image-guided intensity-modulated APBI</description>
    <arm_group_label>Treatment (image-guided intensity-modulated APBI)</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>image-guided radiation therapy</intervention_name>
    <description>Undergo image-guided intensity-modulated APBI</description>
    <arm_group_label>Treatment (image-guided intensity-modulated APBI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>therapeutic conventional surgery</intervention_name>
    <description>Lumpectomy</description>
    <arm_group_label>Treatment (image-guided intensity-modulated APBI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must consent to be in the study and must have signed an approved consent&#xD;
             form conforming with federal and institutional guidelines.&#xD;
&#xD;
          -  Patient must be ≥ 50 years&#xD;
&#xD;
          -  Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.&#xD;
&#xD;
          -  Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.&#xD;
&#xD;
          -  The patient must have clinical node negative, stage I breast cancer.&#xD;
&#xD;
          -  The surgical treatment must be intended to be a lumpectomy&#xD;
&#xD;
          -  The biopsy site must have been demarcated by a clip(s)&#xD;
&#xD;
          -  Gross disease must be unifocal on Mammo/ MRI imaging&#xD;
&#xD;
          -  Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis&#xD;
             performed on core biopsy&#xD;
&#xD;
          -  Patient must be able to tolerate lying in the prone position with arms extended&#xD;
             forward.&#xD;
&#xD;
          -  Must be able to tolerate MRI scan with contrast&#xD;
&#xD;
          -  At the time of enrollment, patients must have had bilateral mammograms within 6&#xD;
             months.&#xD;
&#xD;
          -  Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6&#xD;
             weeks post APBI.&#xD;
&#xD;
          -  Patients with a history of non-breast malignancies are eligible if they have been&#xD;
             disease free for 5 or more years prior to enrollment and are deemed by their&#xD;
             physicians to be at low risk for recurrence. Patients with the following cancers are&#xD;
             eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the&#xD;
             cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous&#xD;
             cell carcinoma of the skin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 50 years&#xD;
&#xD;
          -  Hormone unresponsive breast cancer&#xD;
&#xD;
          -  T-2 ( &gt; 3.0 cm), T-3, Stage III, or Stage IV breast cancer.&#xD;
&#xD;
          -  N-1, N-2, or N-3 clinical axillary nodes&#xD;
&#xD;
          -  Mastectomy intended&#xD;
&#xD;
          -  Unwilling to undergo anti-endocrine therapy&#xD;
&#xD;
          -  Suspicious microcalcification, densities, or palpable abnormalities ( in the&#xD;
             ipsilateral or contralateral breast) unless biopsied and found to be benign.&#xD;
&#xD;
          -  Non-epithelial breast malignancies such as sarcoma or lymphoma.&#xD;
&#xD;
          -  Paget's disease of the nipple&#xD;
&#xD;
          -  Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or&#xD;
             separated by &gt; 4 centimeters.&#xD;
&#xD;
          -  Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone&#xD;
             therapy for the currently diagnosed breast cancer prior to study enrollment.&#xD;
&#xD;
          -  Prior breast or thoracic RT for any condition.&#xD;
&#xD;
          -  Psychiatric of addictive disorders or other condition that in the opinion of the&#xD;
             investigator would preclude the patient from meeting the study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sasha Beyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Sasha Beyer</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Early Stage Breast Cancer</keyword>
  <keyword>Hormone responsive breast cancer</keyword>
  <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>Carcinoma, Ductal, Breast</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/NCT02186470
org study id: OSU-13282
secondary id: NCI-2014-01248
nct id: NCT02186470
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation
      (APBI) before surgery in treating older patients with estrogen receptor positive or
      progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation
      therapy that delivers a high dose of radiation directly to the tumor may kill more tumor
      cells and cause less damage to normal tissue. Giving radiation therapy before surgery may
      make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:

      Establish the feasibility for preoperative APBI delivered with IMRT in the prone position
      using daily CT guidance for Stage I breast cancer patients who are intended to undergo a
      lumpectomy for breast conserving therapy.

      SECONDARY OBJECTIVES:

        1. To determine the acute and late surgical and radiation toxicity of preoperative APBI
           delivered with IMRT in the prone position.

        2. To document the cosmetic appearance of the breast when treated with preoperative APBI
           IMRT in the prone position.

        3. Establish the percentage of patients that can meet dosimetric goals and normal tissue
           constraints if treated with preoperative APBI IMRT in the prone position.

        4. Evaluate molecular changes in breast cancer and/or stroma before and after preoperative
           APBI

      OUTLINE:

      Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone
      position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI,
      patients undergo lumpectomy.

      After completion of treatment, patients are followed up at 4 weeks and then every 6 months
      for 5 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
time frame: 4-6 weeks post-APBI
description: Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).
measure: Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0
time frame: Up to 4 weeks post-surgery
measure: Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0
time frame: Up to 5 years
measure: Cosmetic outcome by the physician and patient
time frame: At year 1
measure: Cosmetic outcome by the physician and patient
time frame: At year 3
measure: In-breast recurrence
time frame: Up to 5 years
measure: Regional recurrence
time frame: Up to 5 years
measure: Distant metastases
time frame: Up to 5 years
measure: Disease free survival
time frame: Up to 5 years
measure: Overall survival
time frame: Up to 5 years
measure: Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs
time frame: Up to 4 weeks post-surgery
description: Correlative analyses
arm group label: Treatment (image-guided intensity-modulated APBI)
arm group type: Experimental
description: Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
intervention type: Radiation
intervention name: accelerated partial breast irradiation
description: Undergo image-guided intensity-modulated APBI
arm group label: Treatment (image-guided intensity-modulated APBI)
other name: APBI
intervention type: Radiation
intervention name: intensity-modulated radiation therapy
description: Undergo image-guided intensity-modulated APBI
arm group label: Treatment (image-guided intensity-modulated APBI)
other name: IMRT
intervention type: Radiation
intervention name: image-guided radiation therapy
description: Undergo image-guided intensity-modulated APBI
arm group label: Treatment (image-guided intensity-modulated APBI)
intervention type: Procedure
intervention name: therapeutic conventional surgery
description: Lumpectomy
arm group label: Treatment (image-guided intensity-modulated APBI)
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Sasha Beyer, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Sasha Beyer
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Carcinoma, Ductal, Breast
sharing ipd: No