<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/NCT01714128</url>
  </required_header>
  <id_info>
    <org_study_id>Dehdashti FES NCI#9167</org_study_id>
    <nct_id>NCT01714128</nct_id>
  </id_info>
  <brief_title>FES-PET for Patients Treated on NCI Protocol 8762</brief_title>
  <official_title>Positron Emission Tomography (PET) With 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients With Breast Cancer Scheduled to be Treated With MK-2206 in Combination With Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A significant number of all invasive breast cancers are hormone sensitive and may be&#xD;
      candidates for treatment with hormonal therapy.&#xD;
&#xD;
      This project will assess the ability and usefulness of imaging hormone-receptor status in&#xD;
      breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES),&#xD;
      an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given&#xD;
      in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 75% of all invasive breast cancers are hormone sensitive [estrogen-receptor&#xD;
      positive (ER+) or progesterone-receptor positive (PR+)] and patients with such cancers are&#xD;
      candidates for endocrine therapy. Endocrine therapy is a central component of the treatment&#xD;
      of hormone-sensitive breast cancer in the adjuvant and, increasingly, neoadjuvant settings.&#xD;
      Knowledge of hormone receptor expression is essential for selection of appropriate therapy.&#xD;
      Measurement of hormone-receptor expression [estrogen receptor (ER) or progesterone receptor&#xD;
      (PR)] using in vitro assays of the tumor tissue at the time of primary diagnosis is standard&#xD;
      of clinical care. However, the presence of these hormone receptors predicts for clinical&#xD;
      benefit in only 30-50% of women with advanced disease receiving first-line endocrine therapy&#xD;
      and 15-30% receiving second-line therapy (1-3). Thus, the presence of a hormone receptor does&#xD;
      not indicate that the receptor is functional and essential to the growth of the cancer cell,&#xD;
      nor does it imply that interference with receptor function will result in tumor cell kill.&#xD;
      There are several shortcomings of the in vitro assays and neither quantitative nor&#xD;
      qualitative receptor assays performed on samples of tumor tissue completely predict the&#xD;
      response to antiestrogen therapy in breast cancers. In addition, none of the current clinical&#xD;
      tools (serologies, prognostic factors, or radiologic studies) can accurately predict for&#xD;
      clinical benefit from endocrine therapy. Accordingly, better methods for predicting clinical&#xD;
      response to antiestrogen therapy need to be developed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study Funding no longer available&#xD;
  </why_stopped>
  <start_date>June 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FES baseline tumor SUV measurement</measure>
    <time_frame>Up to 36 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Optional Diagnostic Imaging</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Optional diagnostic imaging FES-PET/CT imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))</intervention_name>
    <description>FES-PET/CT imaging</description>
    <arm_group_label>Optional Diagnostic Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have agreed and signed consent to participate in NCI protocol 8762 and&#xD;
             be scheduled to receive the first dose of MK-2206 in a minimum of 48 hours and a&#xD;
             maximum of 30 days after the FES-PET/CT imaging.&#xD;
&#xD;
             Note: Patients need to be on the endocrine agent for at least 1 week prior to the&#xD;
             FES-PET/CT imaging.&#xD;
&#xD;
          2. Patients must have measurable disease (defined by RECIST criteria) or the presence of&#xD;
             bone lesions if there is no measurable lesion.&#xD;
&#xD;
          3. Patient must be ≥ 18 years of age.&#xD;
&#xD;
          4. Patient must be able to tolerate and have no contraindication to FES-PET/CT imaging.&#xD;
&#xD;
          5. Patient must be able and willing to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient must have no other active cancer at the time of study entry.&#xD;
&#xD;
          2. The research FES-PET/CT scan could not be scheduled more than 48 hours before starting&#xD;
             therapy with MK-2206.&#xD;
&#xD;
          3. Patient cannot have received treatment for any other malignancy, with the exception of&#xD;
             non-melanoma skin cancer, in the past 5 years.&#xD;
&#xD;
          4. Patients scheduled to receive chemotherapy as the primary source of treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farrokh Dehdashti, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington Univesity in St. Louis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mallinckrodt Institute of Radiology</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Farrokh Dehdashti</investigator_full_name>
    <investigator_title>Professor of Radiology</investigator_title>
  </responsible_party>
  <keyword>NCI protocol #8762</keyword>
  <keyword>Estrogen receptor positive breast cancer</keyword>
  <keyword>recurrent breast cancer</keyword>
  <keyword>stage IV breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
  </intervention_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/NCT01714128
org study id: Dehdashti FES NCI#9167
nct id: NCT01714128
lead sponsor: 
has dmc: Yes
A significant number of all invasive breast cancers are hormone sensitive and may be
      candidates for treatment with hormonal therapy.

      This project will assess the ability and usefulness of imaging hormone-receptor status in
      breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES),
      an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given
      in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .
Approximately 75% of all invasive breast cancers are hormone sensitive [estrogen-receptor
      positive (ER+) or progesterone-receptor positive (PR+)] and patients with such cancers are
      candidates for endocrine therapy. Endocrine therapy is a central component of the treatment
      of hormone-sensitive breast cancer in the adjuvant and, increasingly, neoadjuvant settings.
      Knowledge of hormone receptor expression is essential for selection of appropriate therapy.
      Measurement of hormone-receptor expression [estrogen receptor (ER) or progesterone receptor
      (PR)] using in vitro assays of the tumor tissue at the time of primary diagnosis is standard
      of clinical care. However, the presence of these hormone receptors predicts for clinical
      benefit in only 30-50% of women with advanced disease receiving first-line endocrine therapy
      and 15-30% receiving second-line therapy (1-3). Thus, the presence of a hormone receptor does
      not indicate that the receptor is functional and essential to the growth of the cancer cell,
      nor does it imply that interference with receptor function will result in tumor cell kill.
      There are several shortcomings of the in vitro assays and neither quantitative nor
      qualitative receptor assays performed on samples of tumor tissue completely predict the
      response to antiestrogen therapy in breast cancers. In addition, none of the current clinical
      tools (serologies, prognostic factors, or radiologic studies) can accurately predict for
      clinical benefit from endocrine therapy. Accordingly, better methods for predicting clinical
      response to antiestrogen therapy need to be developed.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: FES baseline tumor SUV measurement
time frame: Up to 36 months
arm group label: Optional Diagnostic Imaging
arm group type: Other
description: Optional diagnostic imaging FES-PET/CT imaging
intervention type: Drug
intervention name: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))
description: FES-PET/CT imaging
arm group label: Optional Diagnostic Imaging
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farrokh Dehdashti, M.D.
role: Principal Investigator
affiliation: Washington Univesity in St. Louis
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Farrokh Dehdashti
investigator title: Professor of Radiology
mesh term: Breast Neoplasms
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Estradiol
mesh term: Polyestradiol phosphate