<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/NCT03778931</url>
  </required_header>
  <id_info>
    <org_study_id>RAD1901-308</org_study_id>
    <nct_id>NCT03778931</nct_id>
  </id_info>
  <brief_title>Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer</brief_title>
  <acronym>EMERALD</acronym>
  <official_title>Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stemline Therapeutics, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stemline Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard&#xD;
      of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with&#xD;
      breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6&#xD;
      inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an international, multicenter, randomized, open-label, active-controlled,&#xD;
      event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the&#xD;
      SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men&#xD;
      with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that&#xD;
      harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene&#xD;
      (ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type&#xD;
      [ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two&#xD;
      prior lines of endocrine therapy (with documented progression), which must have included&#xD;
      prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI)&#xD;
      and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole,&#xD;
      letrozole, exemestane) is an appropriate treatment option.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 10, 2019</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Actual">August 24, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS) in the ESR1-mut subjects</measure>
    <time_frame>From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)</time_frame>
    <description>Progression Free Survival (PFS) based on blinded IRC assessment in the ESR1-mut subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS in all (ESR1-mut and ESR1-WT) subjects</measure>
    <time_frame>From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)</time_frame>
    <description>PFS based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Survival (OS) in ESR1-mut subjects</measure>
    <time_frame>From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)</time_frame>
    <description>OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS in all (ESR1-mut and ESR1-WT) subjects</measure>
    <time_frame>From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)</time_frame>
    <description>OS in all (ESR1-mut and ESR1-WT) subjects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">466</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Elacestrant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in Arm 1 will receive elacestrant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (SoC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elacestrant</intervention_name>
    <description>400 mg/day once daily oral dosing</description>
    <arm_group_label>Elacestrant</arm_group_label>
    <other_name>RAD1901</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle&#xD;
Anastrozole 1 mg/day on a continuous dosing schedule&#xD;
Letrozole: 2.5 mg/day on a continuous dosing schedule&#xD;
Exemestane: 25 mg/day on a continuous dosing schedule</description>
    <arm_group_label>Standard of Care (SoC)</arm_group_label>
    <other_name>Faslodex, Arimidex, Femara, Aromasin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Critical Inclusion Criteria:&#xD;
&#xD;
          1. Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either&#xD;
             locally advanced disease not amenable to resection or radiation therapy with curative&#xD;
             intent or metastatic disease not amenable to curative therapy.&#xD;
&#xD;
          2. Subjects must be appropriate candidates for endocrine monotherapy&#xD;
&#xD;
          3. Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease&#xD;
&#xD;
          4. Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women&#xD;
             and male subjects must not allow pregnancy with their sperm (abstain, do not donate&#xD;
             sperm, etc).&#xD;
&#xD;
          5. Subjects must have ER+/HER2-tumor status&#xD;
&#xD;
          6. Subjects must have previously received at least one and no more than two lines of&#xD;
             endocrine therapy for advanced/metastatic breast cancer and meet additional previous&#xD;
             treatment criteria.&#xD;
&#xD;
          7. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination&#xD;
             with either fulvestrant or an aromatase inhibitor (AI).&#xD;
&#xD;
          8. Subjects may have received no more than one line of chemotherapy in the&#xD;
             advanced/metastatic setting.&#xD;
&#xD;
          9. Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing&#xD;
             with Guardant360CDx® before subject is randomized.&#xD;
&#xD;
        Critical Exclusion Criteria:&#xD;
&#xD;
          1. Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496,&#xD;
             bazedoxifene, or other investigational SERD or investigational ER antagonist.&#xD;
&#xD;
          2. Prior anticancer or investigational drug treatment within the following windows:&#xD;
&#xD;
               1. Fulvestrant treatment &lt; 28 days before first dose of study drug&#xD;
&#xD;
               2. Any endocrine therapy &lt; 14 days before first dose of study drug (with the&#xD;
                  exception of GnRH agonist therapy in male subjects)&#xD;
&#xD;
               3. Chemotherapy &lt; 21 days before first dose of study drug&#xD;
&#xD;
               4. Any investigational anti-cancer drug therapy &lt; 28 days or five half-lives&#xD;
                  (whichever is shorter) before the first dose of study drug. Enrollment of&#xD;
                  subjects whose most recent therapy was an investigational agent should be&#xD;
                  discussed with the Sponsor&#xD;
&#xD;
          3. Presence of symptomatic visceral disease as defined in protocol.&#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>Sr. Director, Clinical Operations</last_name>
    <role>Study Director</role>
    <affiliation>Radius Health, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adventist Health Glendale</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC IDS Pharmacy</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ridley Tree Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA West Medical Pharmacy 159</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TMPN Cancer Care</name>
      <address>
        <city>Redondo Beach</city>
        <state>California</state>
        <zip>90277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center, Investigational Drug Service</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Oncology - Rocky Mountain Cancer Centers - Midtown</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Cancer Institute, P.C. - Oncology</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suburban Hematology-Oncology Associates</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Association for Research and Education in Science</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Research Network II</name>
      <address>
        <city>Tinley Park</city>
        <state>Illinois</state>
        <zip>60487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pikeville Medical Center - Oncology/Hematology</name>
      <address>
        <city>Pikeville</city>
        <state>Kentucky</state>
        <zip>41501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Cancer Specialists</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Oncology Hematology,</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mass General Cancer Center at Newton Wellesley - Oncology</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mass General North Shore Cancer Center - Oncology</name>
      <address>
        <city>Danvers</city>
        <state>Massachusetts</state>
        <zip>01923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Oncology Associates, PLLC.</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Cancer Research</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Barnabas Medical Center - Cancer Center</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Oncology Hematology Consultants - Oncology</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Cancer Care Alliance</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Clinical Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health Cancer Institute</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Hematology Oncology Associates</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Cancer Center</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brig Center For Cancer Care And Survivorship</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Central Austin Cancer Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Willowbrook</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Oncology Research-- Investigational Product Center</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - McAllen</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Therapy and Research Center at UTHSCSA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - The Woodlands, Gynecologic Oncology</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USO Texas Oncology - Tyler</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialists</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Schar Cancer Institute</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Belvoir Community Hospital</name>
      <address>
        <city>Fort Belvoir</city>
        <state>Virginia</state>
        <zip>22060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benaroya Research Institute at Virginia Mason</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico Austral</name>
      <address>
        <city>Buenos Aires</city>
        <state>Ciudad Autónoma De Buenos Aire</state>
        <zip>1019</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion CENIT para la Investigación en Neurociencias - Clinic</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <zip>C1025ABI</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universitaria Reina Fabiola</name>
      <address>
        <city>Córdoba</city>
        <zip>5004</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación CORI</name>
      <address>
        <city>La Rioja</city>
        <zip>5300</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Hospital</name>
      <address>
        <city>Birtinya</city>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macarthur Cancer Therapy</name>
      <address>
        <city>Campbelltown</city>
        <zip>2560</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen GmbH</name>
      <address>
        <city>Wels</city>
        <state>Oberösterreich</state>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus (LKH) Leoben-Eisenerz</name>
      <address>
        <city>Leoben</city>
        <state>Steiermark</state>
        <zip>8700</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Klina</name>
      <address>
        <city>Brasschaat</city>
        <state>Antwerpen</state>
        <zip>2930</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen - Oncologie</name>
      <address>
        <city>Edegem</city>
        <state>Antwerpen</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Turnhout</name>
      <address>
        <city>Turnhout</city>
        <state>Antwerpen</state>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet - Oncologie Médicale</name>
      <address>
        <city>Brussels</city>
        <state>Brussels Capital Region</state>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel - Campus Jette</name>
      <address>
        <city>Brussel</city>
        <state>Brussels Capital Region</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Bruxelles</city>
        <state>Brussels Capital Region</state>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc - Oncology</name>
      <address>
        <city>Bruxelles</city>
        <state>Brussels Capital Region</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de Charleroi - Site Notre-Dame</name>
      <address>
        <city>Charleroi</city>
        <state>Hainaut</state>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INDC Entité Jolimontoise - CH de Jolimont-Lobbes</name>
      <address>
        <city>Haine-Saint-Paul</city>
        <state>Hainaut</state>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Ardenne - Site de Libramont</name>
      <address>
        <city>Libramont</city>
        <state>Luxembourg</state>
        <zip>6800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze-Lieve-Vrouwziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <state>Oost-Vlaanderen</state>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Nikolaas - Campus Sint-Niklaas Moerland</name>
      <address>
        <city>Sint-Niklaas</city>
        <state>Oost-Vlaanderen</state>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology</name>
      <address>
        <city>Brugge</city>
        <state>West-Vlaanderen</state>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <state>West-Vlaanderen</state>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge - Campus Kennedylaan</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur - Site Sainte-Elisabeth</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur Campus Sainte-Elisabeth</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Pierre</name>
      <address>
        <city>Ottignies</city>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacie du CRCHUM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre - Cedars Cancer Center - Oncology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A-3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec - Hopital du Saint Sacrement</name>
      <address>
        <city>Québec</city>
        <zip>G1S 4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus</name>
      <address>
        <city>Vejle</city>
        <state>South Denmark</state>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Næstved Sygehus</name>
      <address>
        <city>Næstved</city>
        <state>Zeeland</state>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg Universitetshospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital - Oncology</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Lutte Contre le Cancer (CLCC)</name>
      <address>
        <city>Caen</city>
        <state>Calvados</state>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Trousseau - Service d'oncologie mÃ©dicale</name>
      <address>
        <city>Tours</city>
        <state>Indre-et-Loire</state>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont Ferrand</city>
        <state>Puy-de-Dôme</state>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse Service Pharmacie</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges Francois Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Jean Mermoz Département Pharmacie</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques&quot;</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre De Lutte Contre Le Cancer - Institut Curie - DÃ©partement d'Oncologie MÃ©dica</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital René Huguenin - Institut Curie - Oncologie médicale</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques&quot;</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IUCT-Oncopole Pharmacie-Essais Cliniques</name>
      <address>
        <city>Toulouse</city>
        <zip>31100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital Of Patras - Dpt Of Medicine, Division Oncology</name>
      <address>
        <city>Patra</city>
        <state>Achaïa</state>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Hospital - Oncology Unit</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>18547</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Larissa</name>
      <address>
        <city>Larissa</city>
        <state>Larisa</state>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinic Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54622</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pécsi Tudományegyetem Klinikai Központ</name>
      <address>
        <city>Pécs</city>
        <state>Baranya</state>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bács-Kiskun Megyei Kórház</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdú-Bihar</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Központ</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdú-Bihar</state>
        <zip>7032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint</name>
      <address>
        <city>Szolnok</city>
        <state>Jász-Nagykun-Szolnok</state>
        <zip>5004</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór</name>
      <address>
        <city>Nyiregyhaza</city>
        <state>Szabolcs-Szatmár-Bereg</state>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uzsoki Utcai Kórház</name>
      <address>
        <city>Budapest</city>
        <zip>1145</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem, Onkológiai Központ,</name>
      <address>
        <city>Budapest</city>
        <zip>H-1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Országos Onkológiai Intézet</name>
      <address>
        <city>Budapest</city>
        <zip>H-1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Hospital [Oncology]</name>
      <address>
        <city>Cork City</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Facility, St. James's Hospital</name>
      <address>
        <city>Sligo</city>
        <zip>F91 H684</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital</name>
      <address>
        <city>Sligo</city>
        <zip>F91 H684</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sligo University Hospital</name>
      <address>
        <city>Sligo</city>
        <zip>F91 H684</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy, UHW</name>
      <address>
        <city>Waterford</city>
        <zip>X91 ER8E</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah MO - Oncology,Hadassah MO</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galilee Medical Center</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center - Beilinson Hospital - Davidoff Cancer</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center - Oncology</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center</name>
      <address>
        <city>Tel-Hashomer</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Zerifin</city>
        <zip>7030000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona</name>
      <address>
        <city>Cremona</city>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DiMI, Dipartimento di Medicina interna e Specialità mediche,</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Gerardo-ASST Monza</name>
      <address>
        <city>Monza</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Maggiore della Carità - SC Oncologia</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SO S.Chiara, AOU Pisana - Oncologia 2</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico A. Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Universitaria Integrata di Udine</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Senhora da Oliveira - Guimarães, E.P.E.</name>
      <address>
        <city>Guimarães</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Luz</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português Oncologia Francisco Gentil do Porto</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucía</state>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>Tenerife</city>
        <state>Canarias</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Xeral Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IOB Ruber Internacional</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velindre Cancer Centre - Oncology</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 2TL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>London</city>
        <zip>W1G 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taunton and Somerset NHS Trust</name>
      <address>
        <city>Taunton</city>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</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>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fulvestrant</mesh_term>
    <mesh_term>Anastrozole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 20, 2023</submitted>
    <returned>April 12, 2023</returned>
    <submitted>August 9, 2023</submitted>
    <returned>September 1, 2023</returned>
  </pending_results>
  <!-- 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/NCT03778931
org study id: RAD1901-308
nct id: NCT03778931
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard
      of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with
      breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6
      inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .
This is an international, multicenter, randomized, open-label, active-controlled,
      event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the
      SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men
      with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that
      harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene
      (ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type
      [ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two
      prior lines of endocrine therapy (with documented progression), which must have included
      prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI)
      and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole,
      letrozole, exemestane) is an appropriate treatment option.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS) in the ESR1-mut subjects
time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
description: Progression Free Survival (PFS) based on blinded IRC assessment in the ESR1-mut subjects
measure: PFS in all (ESR1-mut and ESR1-WT) subjects
time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
description: PFS based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects
measure: Objective Survival (OS) in ESR1-mut subjects
time frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
description: OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause
measure: OS in all (ESR1-mut and ESR1-WT) subjects
time frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
description: OS in all (ESR1-mut and ESR1-WT) subjects
arm group label: Elacestrant
arm group type: Experimental
description: Subjects in Arm 1 will receive elacestrant
arm group label: Standard of Care (SoC)
arm group type: Active Comparator
description: Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
intervention type: Drug
intervention name: Elacestrant
description: 400 mg/day once daily oral dosing
arm group label: Elacestrant
other name: RAD1901
intervention type: Drug
intervention name: Standard of Care
description: Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle
Anastrozole 1 mg/day on a continuous dosing schedule
Letrozole: 2.5 mg/day on a continuous dosing schedule
Exemestane: 25 mg/day on a continuous dosing schedule
arm group label: Standard of Care (SoC)
other name: Faslodex, Arimidex, Femara, Aromasin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sr. Director, Clinical Operations
role: Study Director
affiliation: Radius Health, Inc.
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: France
country: Greece
country: Hungary
country: Ireland
country: Israel
country: Italy
country: Korea, Republic of
country: Portugal
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Fulvestrant
mesh term: Anastrozole
sharing ipd: Yes
submitted: March 20, 2023
returned: April 12, 2023
submitted: August 9, 2023
returned: September 1, 2023