<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/NCT03795012</url>
  </required_header>
  <id_info>
    <org_study_id>MedOPP167</org_study_id>
    <secondary_id>2017-004324-30</secondary_id>
    <nct_id>NCT03795012</nct_id>
  </id_info>
  <brief_title>Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients</brief_title>
  <official_title>A Multicenter, Randomized, Phase II Trial Evaluating the Efficacy of Eribulin Monotherapy and Eribulin Plus Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients After Progression on Endocrine Therapy (REVERT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedSIR</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedSIR</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or&#xD;
      metastatic breast cancer (mBC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or&#xD;
      PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no&#xD;
      prior line of chemotherapy in the metastatic setting, and that have shown progression while&#xD;
      on an aromatase inhibitor-containing regimen in the metastatic setting or within six months&#xD;
      from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at&#xD;
      least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting.&#xD;
      Subjects must have adequate bone marrow and creatinine clearance functions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recruitment rate&#xD;
  </why_stopped>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>Phase 2</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>The overall response rate (ORR)</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>The overall response rate (ORR) in the eribulin + ET arms, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The progression-free survival (PFS)</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>The progression-free survival (PFS) for patients treated with endocrine therapy alone or in combination with eribulin is defined as the time from randomization until death by any cause or objective tumor progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS-2, in the eribulin and the eribulin + ET arms</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>The PFS-2, in the eribulin and the eribulin + ET arms, defined as the time from the randomization to the second disease progression or death, i.e., PFS after the next line of treatment, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) in the eribulin arm</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>The overall response rate (ORR) in the eribulin arm, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of response (DOR) in the eribulin and the eribulin + ET arms</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>The duration of response (DOR) in the eribulin and the eribulin + ET arms, defined as the time from the start of the treatment to disease progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms, defined as the proportion of patients with no disease progression after 6 months of therapy, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The overall survival (OS) in the eribulin and the eribulin + ET arms</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>The overall survival (OS) in the eribulin and the eribulin + ET arms, defined as the length of time that patients remain alive from the start of treatment (OS will be collected at the end of the study).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Tumor shrinkage</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>Maximum Tumor shrinkage, defined as the percentage of tumor shrinkage from baseline (obtained from the sum of the largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)1.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Eribulin monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eribulin plus endocrine therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle, in combination with endocrine therapy (aromatase inhibitor). AI must be identical to the last AI administered to the patient, whether in the adjuvant or metastatic setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin</intervention_name>
    <description>Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.</description>
    <arm_group_label>Eribulin monotherapy</arm_group_label>
    <arm_group_label>eribulin plus endocrine therapy</arm_group_label>
    <other_name>Halaven</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ER-positive and/or PR-positive breast cancer.&#xD;
&#xD;
          -  HER2-negative breast cancer.&#xD;
&#xD;
          -  Unresectable locally advanced or metastatic breast cancer.&#xD;
&#xD;
          -  Confirmed disease progression while in the last aromatase inhibition-containing&#xD;
             regimen in the metastatic setting.&#xD;
&#xD;
          -  At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant&#xD;
             setting.&#xD;
&#xD;
          -  Patients with no prior line of chemotherapy in the metastatic setting.&#xD;
&#xD;
          -  At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting.&#xD;
&#xD;
          -  ECOG score 0 or 1.&#xD;
&#xD;
          -  Patients have adequate bone marrow and organ function.&#xD;
&#xD;
          -  Patients must have measurable disease (RECIST v.1.1).&#xD;
&#xD;
          -  Premenopausal with LHRH analogues for at least 28 days) and postmenopausal women.&#xD;
&#xD;
          -  Patients must agree to not breastfeed during the study and for 3 months after the last&#xD;
             dose of study treatment.&#xD;
&#xD;
          -  Life expectancy greater or equal to 12 weeks.&#xD;
&#xD;
          -  Patients agree to collection of blood samples (liquid biopsy) and optional collection&#xD;
             of metastatic tumour sample (biopsy) at the time of inclusion and progression (if&#xD;
             appropriate).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have received radiation therapy or limited-field palliative radiotherapy within two&#xD;
             weeks prior to Cycle 1, Day 1, or patients who have not recovered from&#xD;
             radiotherapy-related toxicities.&#xD;
&#xD;
          -  Have received prior chemotherapy for locally advanced or metastatic disease.&#xD;
&#xD;
          -  Have peripheral neuropathy grade 2 or greater.&#xD;
&#xD;
          -  QTc &gt; 480 msec on basal assessments, history of congenital or personal history of long&#xD;
             QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled&#xD;
             electrolyte disorders&#xD;
&#xD;
          -  Child-bearing potential women not using highly effective methods of contraception.&#xD;
&#xD;
          -  Known hypersensitivity to eribulin, endocrine therapy or its excipients.&#xD;
&#xD;
          -  Other malignancies within the previous two years except adequately treated basal cell&#xD;
             or squamous cell skin cancer or carcinoma in situ of cervix or breast.&#xD;
&#xD;
          -  Known uncontrolled metastases to the central nervous system (CNS) or any progressing&#xD;
             CNS disease.&#xD;
&#xD;
          -  Have a serious concomitant systemic disorder incompatible with the study.&#xD;
&#xD;
          -  Major surgical procedure or significant traumatic injury within 28 days prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Have received any anti-cancer biology or investigational treatment within 30 days&#xD;
             prior to randomization.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Cortés, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MedSIR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Jaén</name>
      <address>
        <city>Jaen</city>
        <state>Jaén</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron Dexeus</name>
      <address>
        <city>Barcelona</city>
        <state>Please Select</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Català d'Oncologia</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial Universitario de León</name>
      <address>
        <city>León</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz,</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Llatzer</name>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Peset</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>Unresectable</keyword>
  <keyword>ER</keyword>
  <keyword>PR</keyword>
  <keyword>Her2</keyword>
  <keyword>recurrent</keyword>
  <keyword>metastatic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03795012
org study id: MedOPP167
secondary id: 2017-004324-30
nct id: NCT03795012
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or
      metastatic breast cancer (mBC).
Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or
      PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no
      prior line of chemotherapy in the metastatic setting, and that have shown progression while
      on an aromatase inhibitor-containing regimen in the metastatic setting or within six months
      from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at
      least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting.
      Subjects must have adequate bone marrow and creatinine clearance functions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The overall response rate (ORR)
time frame: Baseline up to 27 months
description: The overall response rate (ORR) in the eribulin + ET arms, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
measure: The progression-free survival (PFS)
time frame: Baseline up to 27 months
description: The progression-free survival (PFS) for patients treated with endocrine therapy alone or in combination with eribulin is defined as the time from randomization until death by any cause or objective tumor progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
measure: PFS-2, in the eribulin and the eribulin + ET arms
time frame: Baseline up to 27 months
description: The PFS-2, in the eribulin and the eribulin + ET arms, defined as the time from the randomization to the second disease progression or death, i.e., PFS after the next line of treatment, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
measure: Overall response rate (ORR) in the eribulin arm
time frame: Baseline up to 27 months
description: The overall response rate (ORR) in the eribulin arm, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
measure: The duration of response (DOR) in the eribulin and the eribulin + ET arms
time frame: Baseline up to 27 months
description: The duration of response (DOR) in the eribulin and the eribulin + ET arms, defined as the time from the start of the treatment to disease progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
measure: The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms
time frame: Baseline up to 27 months
description: The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms, defined as the proportion of patients with no disease progression after 6 months of therapy, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
measure: The overall survival (OS) in the eribulin and the eribulin + ET arms
time frame: Baseline up to 27 months
description: The overall survival (OS) in the eribulin and the eribulin + ET arms, defined as the length of time that patients remain alive from the start of treatment (OS will be collected at the end of the study).
measure: Maximum Tumor shrinkage
time frame: Baseline up to 27 months
description: Maximum Tumor shrinkage, defined as the percentage of tumor shrinkage from baseline (obtained from the sum of the largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)1.
arm group label: Eribulin monotherapy
arm group type: Active Comparator
description: Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle
arm group label: eribulin plus endocrine therapy
arm group type: Active Comparator
description: Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle, in combination with endocrine therapy (aromatase inhibitor). AI must be identical to the last AI administered to the patient, whether in the adjuvant or metastatic setting.
intervention type: Drug
intervention name: Eribulin
description: Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.
arm group label: Eribulin monotherapy
arm group label: eribulin plus endocrine therapy
other name: Halaven
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Cortés, PhD
role: Principal Investigator
affiliation: MedSIR
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No