<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/NCT03264651</url>
  </required_header>
  <id_info>
    <org_study_id>CH02ST1</org_study_id>
    <nct_id>NCT03264651</nct_id>
  </id_info>
  <brief_title>Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density</brief_title>
  <official_title>A Single-Centre Pilot Trial Investigating the Efficacy and Safety of Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Havah Therapeutics Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GTx</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Havah Therapeutics Pty Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the impact of a selective androgen receptor modulator combined with an aromatase&#xD;
      inhibitor in reducing high mammographic breast density.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High mammographic breast density is a well recognized risk factor for the development of&#xD;
      breast cancer and the masking of malignancy within the breast. Previous chemoprevention&#xD;
      studies have revealed that only tamoxifen is efficacious in premenopausal women in the&#xD;
      reduction of breast cancer. In order for this to occur mammographic density has to be&#xD;
      reduced. Unfortunately the side effect profile of tamoxifen is such that not many women are&#xD;
      taking up this therapeutic intervention. This trial is trying to establish a combination&#xD;
      therapy to reduce mammographic breast density.&#xD;
&#xD;
      This phase 1 pilot study is combining oral enobosarm, a selective androgen receptor&#xD;
      modulator, and oral anastrozole, an aromatase inhibitor, to study the impact of this&#xD;
      combination treatment on mammographic breast density and breast elasticity. Safety and&#xD;
      tolerability we also analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">March 21, 2018</completion_date>
  <primary_completion_date type="Actual">March 21, 2018</primary_completion_date>
  <phase>Phase 1</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>A single armed group of premenopausal women receiving open labeled medication</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mammographic breast density</measure>
    <time_frame>12 months</time_frame>
    <description>Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast tissue elasticity</measure>
    <time_frame>1 month</time_frame>
    <description>Evaluation of breast elasticity change by direct shear wave ultrasonic measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast tissue elasticity</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation of breast elasticity change by direct shear wave ultrasonic measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast tissue elasticity</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of breast elasticity change by direct shear wave ultrasonic measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breast pain scale</measure>
    <time_frame>1 month, 3 months, 12 months</time_frame>
    <description>Breast pain measured on a 100 mm visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum gonadotropin levels</measure>
    <time_frame>1 month, 3 months, 12 months</time_frame>
    <description>serum follicular stimulating hormone and luteinizing hormone levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopausal symptoms</measure>
    <time_frame>3 months, 12 months</time_frame>
    <description>Menopause symptoms as recorded on a menopause symptoms scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Mammographic Density</condition>
  <arm_group>
    <arm_group_label>oral enobosarm and anastrozole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9 mg of oral enbosarm and 1 mg of anastrozole daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>enobosarm</intervention_name>
    <description>Oral combination therapy of enobosarm and anastrozole</description>
    <arm_group_label>oral enobosarm and anastrozole</arm_group_label>
    <other_name>anastrozole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of written informed consent&#xD;
&#xD;
          -  Pre-menopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone,&#xD;
             oestrogen) according to the definition of &quot;pre-menopausal range&quot; for the laboratory&#xD;
             involved&#xD;
&#xD;
          -  Have a Volpara Density volumetric breast density of &gt;15.5% (combined average both&#xD;
             breasts)&#xD;
&#xD;
          -  Breast pain in the previous month of equal to or greater than 40mm on a 100mm visual&#xD;
             analogue pain scale&#xD;
&#xD;
          -  WBC ≥ 3.0 x 109/L, granulocytes ≥ 1.5 X 109/L and platelets ≥ 100 x 109/L.&#xD;
&#xD;
          -  AST/SGOT or ALT/SGPT ≤ 3 times ULN&#xD;
&#xD;
          -  eGFR&gt; 60 ml/min/1.73m2&#xD;
&#xD;
          -  Negative pregnancy test in women of childbearing potential (premenopausal or less than&#xD;
             12 months of amenorrhea post-menopause, and who have not undergone surgical&#xD;
             sterilization), no more than 7 days before the first dose of study treatment;&#xD;
&#xD;
          -  For women of childbearing potential who are sexually active, agreement to use a highly&#xD;
             effective, non-hormonal form of contraception during and for at least 6 months after&#xD;
             completion of study treatment; OR, a fertile male partner willing and able to use&#xD;
             effective non-hormonal means of contraception (barrier method of contraception in&#xD;
             conjunction with spermicidal jelly, or surgical sterilization) during and for at least&#xD;
             6 months after completion of study treatment;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of breast cancer&#xD;
&#xD;
          -  Diabetes mellitus or glucose intolerance defined as a fasting glucose &gt;6mmol/l&#xD;
&#xD;
          -  Previous or concomitant other (non-breast cancer) malignancy within the previous 5&#xD;
             years (other than skin cancer)&#xD;
&#xD;
          -  History of coronary artery disease&#xD;
&#xD;
          -  Systemic hormonal contraception&#xD;
&#xD;
          -  Risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected&#xD;
             blood&#xD;
&#xD;
          -  Known hypersensitivity to any component of testosterone&#xD;
&#xD;
          -  Unable to comply with study requirements&#xD;
&#xD;
          -  Prolonged systemic corticosteroid treatment&#xD;
&#xD;
          -  Any investigational drugs&#xD;
&#xD;
          -  Systemic hormone replacement therapy&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Known liver disease&#xD;
&#xD;
          -  Current warfarin usage&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen N Birrell, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Havah Therapeutics Pty Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wellend Health</name>
      <address>
        <city>Toorak Gardens</city>
        <state>South Australia</state>
        <zip>5065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Selective androgen receptor modulator</keyword>
  <keyword>Aromatase inhibitor</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anastrozole</mesh_term>
  </intervention_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/NCT03264651
org study id: CH02ST1
nct id: NCT03264651
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the impact of a selective androgen receptor modulator combined with an aromatase
      inhibitor in reducing high mammographic breast density.
High mammographic breast density is a well recognized risk factor for the development of
      breast cancer and the masking of malignancy within the breast. Previous chemoprevention
      studies have revealed that only tamoxifen is efficacious in premenopausal women in the
      reduction of breast cancer. In order for this to occur mammographic density has to be
      reduced. Unfortunately the side effect profile of tamoxifen is such that not many women are
      taking up this therapeutic intervention. This trial is trying to establish a combination
      therapy to reduce mammographic breast density.

      This phase 1 pilot study is combining oral enobosarm, a selective androgen receptor
      modulator, and oral anastrozole, an aromatase inhibitor, to study the impact of this
      combination treatment on mammographic breast density and breast elasticity. Safety and
      tolerability we also analyzed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single armed group of premenopausal women receiving open labeled medication
primary purpose: Treatment
masking: None (Open Label)
measure: Mammographic breast density
time frame: 12 months
description: Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software
measure: Breast tissue elasticity
time frame: 1 month
description: Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
measure: Breast tissue elasticity
time frame: 3 months
description: Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
measure: Breast tissue elasticity
time frame: 6 months
description: Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
measure: Breast pain scale
time frame: 1 month, 3 months, 12 months
description: Breast pain measured on a 100 mm visual analog scale
measure: Serum gonadotropin levels
time frame: 1 month, 3 months, 12 months
description: serum follicular stimulating hormone and luteinizing hormone levels
measure: Menopausal symptoms
time frame: 3 months, 12 months
description: Menopause symptoms as recorded on a menopause symptoms scale
arm group label: oral enobosarm and anastrozole
arm group type: Experimental
description: 9 mg of oral enbosarm and 1 mg of anastrozole daily
intervention type: Drug
intervention name: enobosarm
description: Oral combination therapy of enobosarm and anastrozole
arm group label: oral enobosarm and anastrozole
other name: anastrozole
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Stephen N Birrell, MD PhD
role: Principal Investigator
affiliation: Havah Therapeutics Pty Ltd
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Anastrozole
sharing ipd: No