xml: <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/NCT05965141</url>
    </required_header>
    <id_info>
      <org_study_id>2022-LCYJ-YY01</org_study_id>
      <nct_id>NCT05965141</nct_id>
    </id_info>
    <brief_title>Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer</brief_title>
    <official_title>A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital of Guangzhou Medical University</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>
        This is a prospective phase II, single-center, single-arm clinical study of&#xD;
        platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate&#xD;
        the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab&#xD;
        in first-line treatment of platinum-sensitive relapsed ovarian cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a phase II prospective, single-center, single-arm clinical study for&#xD;
        platinum-sensitive recurrent ovarian cancer. The main objective of this study is to evaluate&#xD;
        the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab&#xD;
        in first-line treatment of platinum-sensitive recurrent ovarian cancer.&#xD;
  &#xD;
        Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24&#xD;
        months.&#xD;
  &#xD;
          1. Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab.&#xD;
  &#xD;
          2. Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every&#xD;
             21 days; Carboplatin: AUC=5~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90&#xD;
             min,d1, every 21 days. The dose can be adjusted according to the state of the patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
    <phase>Phase 1/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>Objective response rate</measure>
      <time_frame>During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.</time_frame>
      <description>The proportion of subjects who achieved PR and CR.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease control rate</measure>
      <time_frame>During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.</time_frame>
      <description>Percentage of subjects who achieved PR, CR, and SD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival time</measure>
      <time_frame>During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.</time_frame>
      <description>The time between the patient's first treatment date and any recorded tumor progression or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical benefit rate</measure>
      <time_frame>During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.</time_frame>
      <description>Percentage of subjects who achieved PR, CR, and SD for at least 24 weeks.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">38</enrollment>
    <condition>Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>Aribulin in combination with carboplatin and bevacizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is a one-arm study without randomization. There was only one trial group of Aribulin combined with carboplatin and bevacizumab.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aribulin;carboplatin;bevacizumab</intervention_name>
      <description>Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.</description>
      <arm_group_label>Aribulin in combination with carboplatin and bevacizumab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with measurable or immeasurable disease (RECIST v1.1) or CA 125 evaluable&#xD;
               disease (GCIG criteria) or histologically confirmed diagnosis of recurrent ovarian&#xD;
               cancer.&#xD;
  &#xD;
            -  First disease recurrence after first-line platinum chemotherapy &gt;6 months.&#xD;
  &#xD;
            -  18 years of age ≤75 years of female.&#xD;
  &#xD;
            -  Expected survival ≥ 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Partial tumor related symptoms.&#xD;
  &#xD;
            -  Partial comorbidity.&#xD;
  &#xD;
            -  Subjects developed new secondary malignancies.&#xD;
  &#xD;
            -  other.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jingqi Chen</last_name>
      <role>Study Chair</role>
      <affiliation>Principal Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jingqi Chen, MD</last_name>
      <phone>18928787238</phone>
      <email>chenjingqi2002@163.com</email>
    </overall_contact>
    <reference>
      <citation>Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.</citation>
      <PMID>22752881</PMID>
    </reference>
    <reference>
      <citation>Ramalingam P. Morphologic, Immunophenotypic, and Molecular Features of Epithelial Ovarian Cancer. Oncology (Williston Park). 2016 Feb;30(2):166-76.</citation>
      <PMID>26892153</PMID>
    </reference>
    <reference>
      <citation>Paik ES, Lee YY, Lee EJ, Choi CH, Kim TJ, Lee JW, Bae DS, Kim BG. Survival analysis of revised 2013 FIGO staging classification of epithelial ovarian cancer and comparison with previous FIGO staging classification. Obstet Gynecol Sci. 2015 Mar;58(2):124-34. doi: 10.5468/ogs.2015.58.2.124. Epub 2015 Mar 16.</citation>
      <PMID>25798426</PMID>
    </reference>
    <reference>
      <citation>Mahmood RD, Morgan RD, Edmondson RJ, Clamp AR, Jayson GC. First-Line Management of Advanced High-Grade Serous Ovarian Cancer. Curr Oncol Rep. 2020 Jun 4;22(6):64. doi: 10.1007/s11912-020-00933-8.</citation>
      <PMID>32494876</PMID>
    </reference>
    <reference>
      <citation>Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21.</citation>
      <PMID>28438473</PMID>
    </reference>
    <reference>
      <citation>Jordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer. 2004 Apr;4(4):253-65. doi: 10.1038/nrc1317. No abstract available.</citation>
      <PMID>15057285</PMID>
    </reference>
    <reference>
      <citation>Smith JA, Wilson L, Azarenko O, Zhu X, Lewis BM, Littlefield BA, Jordan MA. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry. 2010 Feb 16;49(6):1331-7. doi: 10.1021/bi901810u.</citation>
      <PMID>20030375</PMID>
    </reference>
    <reference>
      <citation>Ito K, Hamamichi S, Abe T, Akagi T, Shirota H, Kawano S, Asano M, Asano O, Yokoi A, Matsui J, Umeda IO, Fujii H. Antitumor effects of eribulin depend on modulation of the tumor microenvironment by vascular remodeling in mouse models. Cancer Sci. 2017 Nov;108(11):2273-2280. doi: 10.1111/cas.13392. Epub 2017 Sep 22.</citation>
      <PMID>28869796</PMID>
    </reference>
    <reference>
      <citation>Cortes J, Schoffski P, Littlefield BA. Multiple modes of action of eribulin mesylate: Emerging data and clinical implications. Cancer Treat Rev. 2018 Nov;70:190-198. doi: 10.1016/j.ctrv.2018.08.008. Epub 2018 Aug 21.</citation>
      <PMID>30243063</PMID>
    </reference>
    <reference>
      <citation>Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20.</citation>
      <PMID>21935916</PMID>
    </reference>
    <reference>
      <citation>Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.</citation>
      <PMID>21376385</PMID>
    </reference>
    <reference>
      <citation>Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.</citation>
      <PMID>25605862</PMID>
    </reference>
    <reference>
      <citation>De Angelis C, Bruzzese D, Bernardo A, Baldini E, Leo L, Fabi A, Gamucci T, De Placido P, Poggio F, Russo S, Forestieri V, Lauria R, De Santo I, Michelotti A, Del Mastro L, De Laurentiis M, Giuliano M, De Placido S, Arpino G. Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI). ESMO Open. 2021 Apr;6(2):100054. doi: 10.1016/j.esmoop.2021.100054. Epub 2021 Feb 16. Erratum In: ESMO Open. 2021 Apr;6(2):100097.</citation>
      <PMID>33601296</PMID>
    </reference>
    <reference>
      <citation>Hardy-Bessard AC, Brocard F, Clatot F, Lortholary A, You B, Grenier J, Martin-Babau J, Lucas B, Meunier J, Ferrero JM, Savoye AM, Marti A, Despax R, Moullet I, Emile G. First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study. Breast. 2020 Dec;54:256-263. doi: 10.1016/j.breast.2020.09.011. Epub 2020 Sep 30.</citation>
      <PMID>33188992</PMID>
    </reference>
    <reference>
      <citation>Yuan P, Hu X, Sun T, Li W, Zhang Q, Cui S, Cheng Y, Ouyang Q, Wang X, Chen Z, Hiraiwa M, Saito K, Funasaka S, Xu B. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. doi: 10.1016/j.ejca.2019.02.002. Epub 2019 Mar 29.</citation>
      <PMID>30928806</PMID>
    </reference>
    <reference>
      <citation>Zhao Y, Xie N, Li W, Chen W, Lv Z, Zheng Y, Sun T, Liu J, Zhang J, Hu S, Wang Y, Gong C, Li Y, Xie Y, Ge R, Xu F, Wang B. Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: a multicenter retrospective study. Ther Adv Med Oncol. 2021 Jul 9;13:17588359211030210. doi: 10.1177/17588359211030210. eCollection 2021.</citation>
      <PMID>34290830</PMID>
    </reference>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</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>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bevacizumab</mesh_term>
      <mesh_term>Carboplatin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965141
  org study id: 2022-LCYJ-YY01
  nct id: NCT05965141
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective phase II, single-center, single-arm clinical study of
        platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate
        the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab
        in first-line treatment of platinum-sensitive relapsed ovarian cancer.
  This is a phase II prospective, single-center, single-arm clinical study for
        platinum-sensitive recurrent ovarian cancer. The main objective of this study is to evaluate
        the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab
        in first-line treatment of platinum-sensitive recurrent ovarian cancer.
  
        Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24
        months.
  
          1. Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab.
  
          2. Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every
             21 days; Carboplatin: AUC=5~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90
             min,d1, every 21 days. The dose can be adjusted according to the state of the patient.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate
  time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
  description: The proportion of subjects who achieved PR and CR.
  measure: Disease control rate
  time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
  description: Percentage of subjects who achieved PR, CR, and SD.
  measure: Progression-free survival time
  time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
  description: The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
  measure: Clinical benefit rate
  time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
  description: Percentage of subjects who achieved PR, CR, and SD for at least 24 weeks.
  arm group label: Aribulin in combination with carboplatin and bevacizumab
  arm group type: Experimental
  description: This is a one-arm study without randomization. There was only one trial group of Aribulin combined with carboplatin and bevacizumab.
  intervention type: Drug
  intervention name: Aribulin;carboplatin;bevacizumab
  description: Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.
  arm group label: Aribulin in combination with carboplatin and bevacizumab
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jingqi Chen
  role: Study Chair
  affiliation: Principal Investigator
  last name: Jingqi Chen, MD
  phone: 18928787238
  email: chenjingqi2002@163.com
  citation: Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
  PMID: 22752881
  citation: Ramalingam P. Morphologic, Immunophenotypic, and Molecular Features of Epithelial Ovarian Cancer. Oncology (Williston Park). 2016 Feb;30(2):166-76.
  PMID: 26892153
  citation: Paik ES, Lee YY, Lee EJ, Choi CH, Kim TJ, Lee JW, Bae DS, Kim BG. Survival analysis of revised 2013 FIGO staging classification of epithelial ovarian cancer and comparison with previous FIGO staging classification. Obstet Gynecol Sci. 2015 Mar;58(2):124-34. doi: 10.5468/ogs.2015.58.2.124. Epub 2015 Mar 16.
  PMID: 25798426
  citation: Mahmood RD, Morgan RD, Edmondson RJ, Clamp AR, Jayson GC. First-Line Management of Advanced High-Grade Serous Ovarian Cancer. Curr Oncol Rep. 2020 Jun 4;22(6):64. doi: 10.1007/s11912-020-00933-8.
  PMID: 32494876
  citation: Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21.
  PMID: 28438473
  citation: Jordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer. 2004 Apr;4(4):253-65. doi: 10.1038/nrc1317. No abstract available.
  PMID: 15057285
  citation: Smith JA, Wilson L, Azarenko O, Zhu X, Lewis BM, Littlefield BA, Jordan MA. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry. 2010 Feb 16;49(6):1331-7. doi: 10.1021/bi901810u.
  PMID: 20030375
  citation: Ito K, Hamamichi S, Abe T, Akagi T, Shirota H, Kawano S, Asano M, Asano O, Yokoi A, Matsui J, Umeda IO, Fujii H. Antitumor effects of eribulin depend on modulation of the tumor microenvironment by vascular remodeling in mouse models. Cancer Sci. 2017 Nov;108(11):2273-2280. doi: 10.1111/cas.13392. Epub 2017 Sep 22.
  PMID: 28869796
  citation: Cortes J, Schoffski P, Littlefield BA. Multiple modes of action of eribulin mesylate: Emerging data and clinical implications. Cancer Treat Rev. 2018 Nov;70:190-198. doi: 10.1016/j.ctrv.2018.08.008. Epub 2018 Aug 21.
  PMID: 30243063
  citation: Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20.
  PMID: 21935916
  citation: Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.
  PMID: 21376385
  citation: Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.
  PMID: 25605862
  citation: De Angelis C, Bruzzese D, Bernardo A, Baldini E, Leo L, Fabi A, Gamucci T, De Placido P, Poggio F, Russo S, Forestieri V, Lauria R, De Santo I, Michelotti A, Del Mastro L, De Laurentiis M, Giuliano M, De Placido S, Arpino G. Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI). ESMO Open. 2021 Apr;6(2):100054. doi: 10.1016/j.esmoop.2021.100054. Epub 2021 Feb 16. Erratum In: ESMO Open. 2021 Apr;6(2):100097.
  PMID: 33601296
  citation: Hardy-Bessard AC, Brocard F, Clatot F, Lortholary A, You B, Grenier J, Martin-Babau J, Lucas B, Meunier J, Ferrero JM, Savoye AM, Marti A, Despax R, Moullet I, Emile G. First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study. Breast. 2020 Dec;54:256-263. doi: 10.1016/j.breast.2020.09.011. Epub 2020 Sep 30.
  PMID: 33188992
  citation: Yuan P, Hu X, Sun T, Li W, Zhang Q, Cui S, Cheng Y, Ouyang Q, Wang X, Chen Z, Hiraiwa M, Saito K, Funasaka S, Xu B. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. doi: 10.1016/j.ejca.2019.02.002. Epub 2019 Mar 29.
  PMID: 30928806
  citation: Zhao Y, Xie N, Li W, Chen W, Lv Z, Zheng Y, Sun T, Liu J, Zhang J, Hu S, Wang Y, Gong C, Li Y, Xie Y, Ge R, Xu F, Wang B. Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: a multicenter retrospective study. Ther Adv Med Oncol. 2021 Jul 9;13:17588359211030210. doi: 10.1177/17588359211030210. eCollection 2021.
  PMID: 34290830
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Bevacizumab
  mesh term: Carboplatin
  sharing ipd: No