<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/NCT01669252</url>
  </required_header>
  <id_info>
    <org_study_id>SOLTI-1007</org_study_id>
    <secondary_id>2012-000394-23</secondary_id>
    <nct_id>NCT01669252</nct_id>
  </id_info>
  <brief_title>Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer</brief_title>
  <acronym>NeoEribulin</acronym>
  <official_title>A Phase II, Open-label, Single-arm, Exploratory Pharmacogenomic Study of Single Agent Eribulin (HALAVEN®) as Neoadjuvant Treatment for Operable Stage I-II HER2 Non-overexpressing Breast Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SOLTI Breast Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SOLTI Breast Cancer Research Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory&#xD;
      pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with&#xD;
      operable Stage III HER2 non-overexpressing breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of pre-treatment relative abundance of hundreds of mRNA transcripts from primary breast tumors with pCRB after neoadjuvant treatment with eribulin.</measure>
    <time_frame>At the time of definitive surgery.</time_frame>
    <description>pCRB , defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of pCRB, defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of pCRBL, defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination at the time of definitive surgery.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical and radiological ORR, defined by RECIST 1.1</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of mRNA expression in breast tumors with clinical and radiological ORR at different time points during the neoadjuvant treatment with eribulin.</measure>
    <time_frame>Up to 21 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of pCRB according to breast cancer subtype: Luminal A, Luminal B, Basal-like, HER2-enriched and Claudin-low.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of pCRB according to breast cancer subtype determined by immunohistochemistry (following the 2011 St. Gallen definitions): Luminal A, Luminal B, and TNBC.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients able to have breast conservation surgery after being treated with eribulin as neoadjuvant therapy.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between alternations in tubulin isotype expression and mutational status in pre-treatment samples with efficacy parameters, such as pCRB, ORR and BOR.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between exome or genome sequencing data from pre-treatment samples with pCRB after neoadjuvant treatment with eribulin.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in gene expression and gene mutational status between the pre-treatment samples and samples after treatment.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with AEs and serious AEs (assessed by CTCAE v.4)</measure>
    <time_frame>Up to 21 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who had neutropenia Grade 3-4</measure>
    <time_frame>Up to 21 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with neuropathy</measure>
    <time_frame>Up to 21 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of dose reductions and/or dose delays due to treatment toxicity</measure>
    <time_frame>Up to 71 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the expression of mRNA from breast tumors</measure>
    <time_frame>At screening</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the expression of mRNA from breast tumors</measure>
    <time_frame>At 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the expression of mRNA from breast tumors</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of mRNA expression in breast tumors after 21 days of neoadjuvant treatment and at surgery with pCRB.</measure>
    <time_frame>At the time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.</measure>
    <time_frame>At screening</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.</measure>
    <time_frame>At 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.</measure>
    <time_frame>At time of definitive surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of the gene expression analysis of samples to predict clinical response to eribulin.</measure>
    <time_frame>At screening</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of the gene expression analysis of samples to predict clinical response to eribulin.</measure>
    <time_frame>At 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of the gene expression analysis of samples to predict clinical response to eribulin.</measure>
    <time_frame>At time of definitive surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Eribulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin</intervention_name>
    <description>1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.</description>
    <arm_group_label>Eribulin</arm_group_label>
    <other_name>Halaven(R)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent, specifically highlighting the molecular characterization of&#xD;
             tumor and genomic samples&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Histologically confirmed invasive breast carcinoma, with all of the following&#xD;
             characteristics:&#xD;
&#xD;
               -  Primary tumor ≥2cm in largest diameter (cT1-3)&#xD;
&#xD;
               -  cN0-1&#xD;
&#xD;
               -  No evidence of distant metastasis (M0)&#xD;
&#xD;
          -  Breast cancer (BC) eligible for primary surgery&#xD;
&#xD;
          -  Available pre-treatment core (Tru-cut) biopsy or possibility of performing one&#xD;
&#xD;
          -  HER2-negative BC (as per local assessment), defined as either of the following:&#xD;
&#xD;
               -  0-1+ expression by IHC&#xD;
&#xD;
               -  2+ expression by IHC and in situ hybridization (FISH/CISH) without HER2 gene&#xD;
                  amplification (&lt;4 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies&#xD;
                  to Cr17 signals] of &lt;1.8)&#xD;
&#xD;
               -  Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently&#xD;
                  of IHC&#xD;
&#xD;
          -  Known hormone receptor (ER/PgR) status (as per local assessment) or the possibility of&#xD;
             performing the tests&#xD;
&#xD;
          -  Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per&#xD;
             local assessment), or possibility of performing the tests&#xD;
&#xD;
          -  In the case of a multifocal tumor, the largest lesion must be ≥2 cm and designated the&#xD;
             &quot;target&quot; lesion for all subsequent tumor evaluations and HER2-negative status must be&#xD;
             documented in all the tumor foci&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  Laboratory values as follows:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥1.5 x 109/L&#xD;
&#xD;
               -  Platelets count ≥100 x 109/L&#xD;
&#xD;
               -  Hemoglobin ≥9 g/dL&#xD;
&#xD;
               -  Serum bilirubin ≤1.5 time the upper limit of normal (ULN)&#xD;
&#xD;
               -  Alanine aminotransferase and aspartate aminotransferase (AST) ≤2.5 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase ≤2.5 x ULN&#xD;
&#xD;
               -  Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/m&#xD;
&#xD;
          -  Absence of any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule&#xD;
&#xD;
          -  Ability and willingness to comply with study visits, treatment, testing, and to comply&#xD;
             with the protocol&#xD;
&#xD;
          -  Availability of genomic DNA (via whole blood)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prior treatment for primary invasive BC&#xD;
&#xD;
          -  Metastatic, locally advanced or inflammatory (i.e., Stage III-IV) BC&#xD;
&#xD;
          -  Bilateral invasive BC&#xD;
&#xD;
          -  Multicentric BC, defined as the presence of two or more foci of cancer in different&#xD;
             quadrants of the same breast&#xD;
&#xD;
          -  Pre-existing peripheral neuropathy of any grade&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic &gt;150 mmHg and/or diastolic &gt;100 mmHg)&#xD;
&#xD;
          -  Clinically significant (i.e., active) cardiovascular disease&#xD;
&#xD;
          -  Long QT syndrome&#xD;
&#xD;
          -  Concomitant use of inhibitors of hepatic transport proteins such as organic&#xD;
             anion-transporting proteins, P-glycoprotein, multidrug resistant proteins etc&#xD;
&#xD;
          -  Major medical conditions that might affect study participation (e.g., uncontrolled&#xD;
             seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or&#xD;
             uncontrolled infection)&#xD;
&#xD;
          -  Other primary malignant tumors within the previous 5 years, except for adequately&#xD;
             controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix&#xD;
&#xD;
          -  Known human immunodeficiency virus(HIV) infection or other active or serious infection&#xD;
             requiring IV antibiotics at randomization&#xD;
&#xD;
          -  Pregnancy or breastfeeding women&#xD;
&#xD;
          -  Women of childbearing potential(&lt;2 years after the last menstruation) not using&#xD;
             effective, non-hormonal means of contraception during the study and for a period of 6&#xD;
             months following the last administration of study drug&#xD;
&#xD;
          -  Administration of any live virus vaccine within 8 weeks preceding study entry&#xD;
&#xD;
          -  Use of any investigational agent within 30 days of administration of the first dose of&#xD;
             study drug or concurrent treatment on another clinical study&#xD;
&#xD;
          -  Requirement for radiation therapy concurrent with study anticancer treatment&#xD;
&#xD;
          -  Known hypersensitivity to any of the study drugs or excipients&#xD;
&#xD;
          -  Inability or unwillingness to abide by the study protocol or cooperate fully with the&#xD;
             investigator or designee&#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>Javier Cortés, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Vall d´Hebron</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aleix Prat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vall d´Hebron Institut d´Oncologia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum des Landkreises Deggendorf Frauenklinik Mammazentrum</name>
      <address>
        <city>Deggendorf</city>
        <zip>94469</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum im Krankenhaus Köln-Holweide Priv. Doz.</name>
      <address>
        <city>Köln</city>
        <zip>51067</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum der Universität München</name>
      <address>
        <city>Munic</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Südstadt Rostock, Universitätsfrauenklinik und Poliklinik</name>
      <address>
        <city>Rostock</city>
        <zip>18059</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE</name>
      <address>
        <city>Coimbra</city>
        <zip>3001-651</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 Portugues de Oncologia de Porto Francisco Gentil, EPE</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d´Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d´Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Castellón</name>
      <address>
        <city>Castelló de la Plana</city>
        <zip>12002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario San Pedro de Alcántara</name>
      <address>
        <city>Cáceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Marina Salud de Denia</name>
      <address>
        <city>Denia</city>
        <zip>03700</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaén</name>
      <address>
        <city>Jaén</city>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Arnau de Vilanova de Lleida</name>
      <address>
        <city>Lleida</city>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro de Majadahonda</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Sant Joan de Reus</name>
      <address>
        <city>Reus</city>
        <zip>43201</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Torrevieja</name>
      <address>
        <city>Torrevieja</city>
        <zip>03186</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>Hospital Arnau de Vilanova de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Portugal</country>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.gruposolti.org</url>
    <description>SOLTI Breast Cancer Research Group</description>
  </link>
  <reference>
    <citation>Prat P, Llombart A, de la Peña L, Di Cosimo S, Oliveira M, Ortega V, Rubio I, Muñoz E, Harbeck N, Cortés J. NeoEribulin: A Phase II, non-randomized, open-label, single-arm, multicenter, exploratory pharmacogenomic study of single agent eribulin as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.</citation>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>October 31, 2017</last_update_submitted>
  <last_update_submitted_qc>October 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Eribulin</keyword>
  <keyword>Neoadjuvant</keyword>
  <keyword>PAM50</keyword>
  <keyword>Triple-negative</keyword>
  <keyword>Luminal A</keyword>
  <keyword>Luminal B</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT01669252
org study id: SOLTI-1007
secondary id: 2012-000394-23
nct id: NCT01669252
lead sponsor: 
collaborator: 
has dmc: Yes
This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory
      pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with
      operable Stage III HER2 non-overexpressing breast cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Correlation of pre-treatment relative abundance of hundreds of mRNA transcripts from primary breast tumors with pCRB after neoadjuvant treatment with eribulin.
time frame: At the time of definitive surgery.
description: pCRB , defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines
measure: Rate of pCRB, defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines.
time frame: At the time of definitive surgery
measure: Rate of pCRBL, defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination at the time of definitive surgery.
time frame: At the time of definitive surgery
measure: Clinical and radiological ORR, defined by RECIST 1.1
time frame: At the time of definitive surgery
measure: Correlation of mRNA expression in breast tumors with clinical and radiological ORR at different time points during the neoadjuvant treatment with eribulin.
time frame: Up to 21 weeks
measure: Rate of pCRB according to breast cancer subtype: Luminal A, Luminal B, Basal-like, HER2-enriched and Claudin-low.
time frame: At the time of definitive surgery
measure: Rate of pCRB according to breast cancer subtype determined by immunohistochemistry (following the 2011 St. Gallen definitions): Luminal A, Luminal B, and TNBC.
time frame: At the time of definitive surgery
measure: Proportion of patients able to have breast conservation surgery after being treated with eribulin as neoadjuvant therapy.
time frame: At the time of definitive surgery
measure: The correlation between alternations in tubulin isotype expression and mutational status in pre-treatment samples with efficacy parameters, such as pCRB, ORR and BOR.
time frame: At the time of definitive surgery
measure: The correlation between exome or genome sequencing data from pre-treatment samples with pCRB after neoadjuvant treatment with eribulin.
time frame: At the time of definitive surgery
measure: Changes in gene expression and gene mutational status between the pre-treatment samples and samples after treatment.
time frame: At the time of definitive surgery
measure: Number of participants with AEs and serious AEs (assessed by CTCAE v.4)
time frame: Up to 21 weeks
measure: Percentage of patients who had neutropenia Grade 3-4
time frame: Up to 21 weeks
measure: Percentage of subjects with neuropathy
time frame: Up to 21 weeks
measure: Incidence of dose reductions and/or dose delays due to treatment toxicity
time frame: Up to 71 days
measure: Analysis of the expression of mRNA from breast tumors
time frame: At screening
measure: Analysis of the expression of mRNA from breast tumors
time frame: At 21 days
measure: Analysis of the expression of mRNA from breast tumors
time frame: At the time of definitive surgery
measure: Correlation of mRNA expression in breast tumors after 21 days of neoadjuvant treatment and at surgery with pCRB.
time frame: At the time of definitive surgery
measure: Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
time frame: At screening
measure: Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
time frame: At 21 days
measure: Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
time frame: At time of definitive surgery
measure: Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
time frame: At screening
measure: Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
time frame: At 21 days
measure: Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
time frame: At time of definitive surgery
arm group label: Eribulin
arm group type: Experimental
description: 1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.
intervention type: Drug
intervention name: Eribulin
description: 1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.
arm group label: Eribulin
other name: Halaven(R)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Cortés, MD
role: Principal Investigator
affiliation: Hospital Universitario Vall d´Hebron
last name: Aleix Prat, MD
role: Principal Investigator
affiliation: Vall d´Hebron Institut d´Oncologia
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country: France
country: Germany
country: Portugal
country: Spain
url: http://www.gruposolti.org
description: SOLTI Breast Cancer Research Group
citation: Prat P, Llombart A, de la Peña L, Di Cosimo S, Oliveira M, Ortega V, Rubio I, Muñoz E, Harbeck N, Cortés J. NeoEribulin: A Phase II, non-randomized, open-label, single-arm, multicenter, exploratory pharmacogenomic study of single agent eribulin as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.
responsible party type: Sponsor
mesh term: Breast Neoplasms