<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/NCT03786094</url>
  </required_header>
  <id_info>
    <org_study_id>POL6326-009</org_study_id>
    <nct_id>NCT03786094</nct_id>
  </id_info>
  <brief_title>Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer</brief_title>
  <acronym>FORTRESS</acronym>
  <official_title>An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Polyphor Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Polyphor Ltd.</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 is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to&#xD;
      investigate the efficacy, safety and tolerability of intravenous balixafortide given with&#xD;
      eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or&#xD;
      Metastatic Breast Cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 14, 2019</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 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 as assessed by Independent Review Committee</measure>
    <time_frame>12 months after last patient randomized</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">384</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <condition>Locally Recurrent Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Eribulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Balixafortide + eribulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin</intervention_name>
    <description>Eribulin alone</description>
    <arm_group_label>Balixafortide + eribulin</arm_group_label>
    <arm_group_label>Eribulin</arm_group_label>
    <other_name>Eribulin Injection [Halaven]</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Balixafortide</intervention_name>
    <description>balixafortide + eribulin</description>
    <arm_group_label>Balixafortide + eribulin</arm_group_label>
    <other_name>POL6326</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed Breast cancer&#xD;
&#xD;
          -  Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally&#xD;
             recurrent breast cancer&#xD;
&#xD;
          -  refractory to the most recent chemotherapy, documented by progression on or within six&#xD;
             (6) months of therapy&#xD;
&#xD;
          -  At least 14 days from the completion of any previous cancer therapy&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Life expectancy of 3 months or more&#xD;
&#xD;
          -  Willing and able to comply with the protocol and able to understand and willing to&#xD;
             sign an informed consent&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Previously treated with eribulin&#xD;
&#xD;
          -  Peripheral neuropathy Grade ≥3&#xD;
&#xD;
          -  Receipt of prior CXCR4 therapy&#xD;
&#xD;
          -  Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or&#xD;
             sargramostim, or radiation therapy within 14 days prior to study Day 1&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to balixafortide or eribulin or other agents used in the study&#xD;
&#xD;
          -  Breast feeding or pregnant&#xD;
&#xD;
          -  Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias,&#xD;
             known congenital long QT syndrome, QT interval corrected with Fridericia's formula&#xD;
             (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently&#xD;
             taking drugs at known risk of prolonging the QT interval or causing torsades de&#xD;
             pointes&#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>François Ringeisen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Polyphor Ltd.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter A Kaufman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UVM medical center; USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Javier Cortes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IOB and VHIO; Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Cancer Associates for Research and Excellence</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Mount Zion Cancer Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Center South Bay</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwalk Hospital</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06856</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists SOUTH - SCRI - PPDS</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists NORTH - SCRI - PPDS</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists PAN - SCRI - PPDS</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Memorial HealthCare</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists EAST - SCRI - PPDS</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Cancer and Blood Center, LLC</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Cancer Institute PC</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orchard Healthcare Research Inc</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herbert-Herman Cancer Center, Sparrow Hospital</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Piper Cancer Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute 150 Entrance</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCA Midwest Health - SCRI - PPDS</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Research Oncology</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Health St. Francis</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Hospital Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute Hematology Oncology</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee Women's Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Tennessee</city>
        <state>Tennessee</state>
        <zip>37204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan</name>
      <address>
        <city>San Juan</city>
        <state>Buenos Aires</state>
        <zip>J5402DIL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Clínica - Clínica Viedma</name>
      <address>
        <city>Viedma</city>
        <state>Río Negro</state>
        <zip>8500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Parque de Rosario</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAIPO Centro para la atención integral del paciente oncológico</name>
      <address>
        <city>San Miguel De Tucumán</city>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hopital de Charleroi asbl</name>
      <address>
        <city>Charleroi</city>
        <state>Hainaut</state>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Antwerpen</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHIREC Centre Hospitalier Interregional Edith Cavell</name>
      <address>
        <city>Brussels</city>
        <zip>1160</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Oncologia Da Bahia</name>
      <address>
        <city>Bahia</city>
        <zip>41820-021</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade de Caxias do Sul (IPCEM-UCS)</name>
      <address>
        <city>Caxias Do Sul</city>
        <zip>95070-560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner</name>
      <address>
        <city>Curitiba</city>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INCA Instituto Nacional De Cancer</name>
      <address>
        <city>Rio De Janeiro</city>
        <zip>20560-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto</name>
      <address>
        <city>São José Do Rio Preto</city>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda</name>
      <address>
        <city>São Paulo</city>
        <zip>01317-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiscan s.r.o - Onkologická ambulance</name>
      <address>
        <city>Hořovice</city>
        <zip>28831</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Králové</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice v Motole</name>
      <address>
        <city>Prague</city>
        <zip>15000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EDOG - Institut Claudius Regaud - PPDS</name>
      <address>
        <city>Toulouse</city>
        <zip>31100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele S.r.l. - PPDS</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST di Monza - Azienda Ospedaliera San Gerardo</name>
      <address>
        <city>Monza</city>
        <state>Milano</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria - Università degli studi della Campania &quot;Luigi Vanvitelli&quot;</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <zip>10408</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>Seul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Evimed</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454048</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Tonus</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603089</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budgetary Healthcare Institution of the Omsk region &quot;Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evromedservis LCC</name>
      <address>
        <city>Pushkin</city>
        <zip>196603</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mordovia State University</name>
      <address>
        <city>Saransk</city>
        <zip>430000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Oncology Institute of Tomsk Scientific Center</name>
      <address>
        <city>Tomsk</city>
        <zip>634009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volgograd Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Volgograd</city>
        <zip>400138</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO l'Hospitalet - Hospital Duran i Reynals</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quironsalud Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>8023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Arnau de Vilanova</name>
      <address>
        <city>Lleida</city>
        <state>Cataluña</state>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Badajoz</name>
      <address>
        <city>Badajoz</city>
        <zip>06006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall D'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ruber Internacional</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Medical Center, Liouying</name>
      <address>
        <city>Tainan City</city>
        <zip>736</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koo Foundation Sun Yat-Sen Cancer Center</name>
      <address>
        <city>Taipei</city>
        <zip>11259</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Medical Center Family Medicine Clinic</name>
      <address>
        <city>Dnipro</city>
        <zip>49600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution SubCarpathian Clinical Oncological Centre</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre</name>
      <address>
        <city>Lviv</city>
        <zip>79031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Cancer Institute</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</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>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786094
org study id: POL6326-009
nct id: NCT03786094
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to
      investigate the efficacy, safety and tolerability of intravenous balixafortide given with
      eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or
      Metastatic Breast Cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival as assessed by Independent Review Committee
time frame: 12 months after last patient randomized
arm group label: Eribulin
arm group type: Active Comparator
arm group label: Balixafortide + eribulin
arm group type: Experimental
intervention type: Drug
intervention name: Eribulin
description: Eribulin alone
arm group label: Balixafortide + eribulin
arm group label: Eribulin
other name: Eribulin Injection [Halaven]
intervention type: Drug
intervention name: Balixafortide
description: balixafortide + eribulin
arm group label: Balixafortide + eribulin
other name: POL6326
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: François Ringeisen, MD
role: Study Director
affiliation: Polyphor Ltd.
last name: Peter A Kaufman, MD
role: Principal Investigator
affiliation: UVM medical center; USA
last name: Javier Cortes, MD
role: Principal Investigator
affiliation: IOB and VHIO; Spain
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country: Argentina
country: Belgium
country: Brazil
country: Czechia
country: France
country: Italy
country: Korea, Republic of
country: Russian Federation
country: Spain
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
country: Germany
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Recurrence