<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/NCT02263495</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0857</org_study_id>
    <nct_id>NCT02263495</nct_id>
  </id_info>
  <brief_title>Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer</brief_title>
  <acronym>EG_PG</acronym>
  <official_title>A Phase II, Multicenter, Randomized Trial of Eribulin Plus Gemcitabine (EG) vs.Paclitaxel Plus Gemcitabine (PG) in Patients With HER2-Negative Metastatic Breast Cancer as First -Line Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samyang Biopharmaceuticals Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective&#xD;
      chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the&#xD;
      preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a&#xD;
      maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as shown&#xD;
      in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin Oncol&#xD;
      31(14):1732, 2013).&#xD;
&#xD;
      Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival&#xD;
      benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of&#xD;
      anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011).&#xD;
      Eribulin was also reported its promising efficacy in another randomized phase III study that&#xD;
      demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS&#xD;
      2012). Both study results showed potential clinical benefit in patients with triple negative&#xD;
      MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for early&#xD;
      line therapy in patients with metastatic breast cancer.&#xD;
&#xD;
      Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of&#xD;
      neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity&#xD;
      profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in&#xD;
      a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared&#xD;
      to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG.&#xD;
&#xD;
      In phase I trial, eribulin in combination with gemcitabine was feasible in patients with&#xD;
      advanced solid tumor treated with chemotherapy (&lt; 3 lines) (Goel R, et al, 2009 ASCO).&#xD;
&#xD;
      Based on this rationale, the investigators are to conduct randomized phase II study comparing&#xD;
      EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as first-line&#xD;
      chemotherapy.&#xD;
&#xD;
      A total of 118 patients will be recruited. Patients will be randomized to a treatment arm by&#xD;
      permutated method. The randomization ratio is 1:1. This study is multi-center, randomized,&#xD;
      open label study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of enrolled 118 patients in EG and PG groups, will be provided chemotherapy regimen:&#xD;
&#xD;
      Paclitaxel/Gemcitabine (PG) : every 3 weeks D1 Paclitaxel 175mg/m2 + D5W 500mL MIV over 3hrs&#xD;
      before gemcitabine administration D1, D8 Gemcitabine 1,250 mg/m2 + NormalSaline 100ml MIV&#xD;
      over 30mins&#xD;
&#xD;
        -  Pre &amp; Post medication (which can be changed according to institutions' policy) D1&#xD;
           Corticosteroid 100 mg i.v. 30 min. before Paclitaxel Pheniramine 1A + D5W 50mL MIV&#xD;
           30mins before Paclitaxel Ranitidine 50mg IV + D5W 50mL MIV 30mins before Paclitaxel HT3&#xD;
           antagonist 1A + D5W 50 mL MIV 30mins before Paclitaxel&#xD;
&#xD;
      Eribulin/Gemcitabine (EG): every 3weeks D1, D8 Eribulin 1.0 mg/m2, 2-5min iv before&#xD;
      gemcitabine (or miv with NormalSaline 100ml in max.) D1, D8 Gemcitabine 1000 mg/m2 +&#xD;
      NormalSaline100ml MIV over 30mins&#xD;
&#xD;
      &lt;schedule of Assessment adn procedures (±3 days window period ) &gt;&#xD;
&#xD;
        1. screening /baseline&#xD;
&#xD;
             -  obtaining Informed consent form&#xD;
&#xD;
             -  collecting information&#xD;
&#xD;
             -  demographic data&#xD;
&#xD;
             -  breast cancer treatment history/ medical history&#xD;
&#xD;
             -  general physical examination/ vital sign &amp; Performance status&#xD;
&#xD;
             -  Test: CBC/blood chemistry/ Tumor response(CT or MRI)/&#xD;
&#xD;
             -  collecting QOL questionnaire using FACT-Taxane&#xD;
&#xD;
        2. cycle 1 ~ prior to EOT&#xD;
&#xD;
             -  general physical examination/ vital sign &amp; Performance status&#xD;
&#xD;
             -  Test: CBC/blood chemistry/ Tumor response(CT or MRI)&#xD;
&#xD;
             -  collecting QOL questionnaire using FACT-Taxane&#xD;
&#xD;
             -  administration PG or EG&#xD;
&#xD;
        3. EOT(end of treatment)&#xD;
&#xD;
             -  general physical examination/ vital sign &amp; Performance status&#xD;
&#xD;
             -  Test: CBC/blood chemistry/ Tumor response(CT or MRI)&#xD;
&#xD;
             -  collecting QOL questionnaire using FACT-Taxane&#xD;
&#xD;
        4. survival follow up(every 12weeks)&#xD;
&#xD;
             -  survival&#xD;
&#xD;
             -  anti neoplastic therapy after end of treatment&#xD;
&#xD;
             -  The tumor response will be performed every 12 (±2) weeks until disease progression&#xD;
&#xD;
      &lt;WITHDRAWAL OF SUBJECTS&gt;&#xD;
&#xD;
      Subjects may be withdrawn from the study (i.e. from any further study medication or study&#xD;
      procedure) for the following reasons:&#xD;
&#xD;
        -  At their own request&#xD;
&#xD;
        -  If, in the investigator's opinion, continuation in the study would be detrimental to the&#xD;
           subject's well-being&#xD;
&#xD;
        -  In case of disease progression&#xD;
&#xD;
        -  In case of unacceptable toxicity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2014</start_date>
  <completion_date type="Actual">June 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 11, 2017</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>Progression free survival</measure>
    <time_frame>48months</time_frame>
    <description>To demonstrate that EG is not inferior to PG group in terms of PFS in patients with metastatic or recurrent breast cancer as first-line treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>48months</time_frame>
    <description>Survival will be measured as the time from randomization to the date of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropathic scale</measure>
    <time_frame>expected at 9week , expected at 24week</time_frame>
    <description>FACT for Taxane QOL assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>toxicity of study drugs</measure>
    <time_frame>from first administration until 28 days after the last dose administration</time_frame>
    <description>Using CTCAE Version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of response</measure>
    <time_frame>48months</time_frame>
    <description>using RECIEST version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>objective response rate</measure>
    <time_frame>48months</time_frame>
    <description>using RECIEST version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical benefit rate</measure>
    <time_frame>48months</time_frame>
    <description>using RECIEST version 1.1</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Paclitaxel &amp; Gemcitabine(PG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paclitaxel 175mg/m2 IV , Day1,every 3weeks Gemcitabine 1250mg/m2 IV ,Day1&amp; Day8 every 3weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eribulin &amp; Gemcitabine(EG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eribulin 1.0 mg/m2, 2-5min iv ,Day1&amp; Day8 every 3weeks Gemcitabine 1,000 mg/m2 ,Day1&amp; Day8 every 3weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>175mg/m2 + D5W 500mL MIV over 3hrs before gemcitabine administration</description>
    <arm_group_label>Paclitaxel &amp; Gemcitabine(PG)</arm_group_label>
    <other_name>Genexol,</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin</intervention_name>
    <description>1.0 mg/m2, 2-5min iv before gemcitabine (or miv with NS 100ml in max.)</description>
    <arm_group_label>Eribulin &amp; Gemcitabine(EG)</arm_group_label>
    <other_name>Halaven,</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>PG:1250mg/m2 + NS 100ml MIV over 30mins EG:1000mg/m2 + NS 100ml MIV over 30mins</description>
    <arm_group_label>Eribulin &amp; Gemcitabine(EG)</arm_group_label>
    <arm_group_label>Paclitaxel &amp; Gemcitabine(PG)</arm_group_label>
    <other_name>Gemcit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed metastatic, or recurrent breast cancer&#xD;
&#xD;
          2. HER2-negative breast cancer&#xD;
&#xD;
          3. age &gt; 18 years&#xD;
&#xD;
          4. ECOG performance status 0 - 2&#xD;
&#xD;
          5. Pre- or postmenopausal breast cancer patients with measurable or non-measurable&#xD;
             lesions, who are candidates for chemotherapy&#xD;
&#xD;
          6. Life expectancy ≥ 3 months&#xD;
&#xD;
          7. No prior history of chemotherapy for metastatic, recurrent breast cancer&#xD;
&#xD;
          8. Patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it&#xD;
             has been 12 months since completion of regimen.&#xD;
&#xD;
          9. Patients either may or may not have a prior anthracycline containing regimen.&#xD;
&#xD;
         10. Prior hormonal therapy as a treatment of metastatic disease is allowed. But&#xD;
             antitumoral hormonal therapy must be terminated prior to enrollment(up to the date of&#xD;
             randomization)&#xD;
&#xD;
         11. Prior radiation therapy allowed as long as &lt; 25% of the bone marrow has been treated,&#xD;
             and the patients must have recovered from the acute toxic effects of the treatment&#xD;
             prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior&#xD;
             radiotherapy must be completed 2 weeks before study entry.&#xD;
&#xD;
         12. Bisphosphonates for the treatment of bone metastases should not be initiated following&#xD;
             the first dose of randomized therapy. It must be initiated prior to day of treatment&#xD;
             (cycle 1, day 1). Patients may continue on bisphosphonates who already established on&#xD;
             bisphosphonate therapy for bone metastases&#xD;
&#xD;
         13. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0&#xD;
             g/dl)&#xD;
&#xD;
         14. Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)&#xD;
&#xD;
         15. Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST &amp; ALTX3 upper normal limit&#xD;
             or AST and ALT ≤ 5.0XULN if judged by the investigator to be related to liver&#xD;
             metastases)&#xD;
&#xD;
         16. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious uncontrolled intercurrent infections&#xD;
&#xD;
          2. Serious intercurrent medical or psychiatric illness, including active cardiac disease&#xD;
&#xD;
          3. Pregnancy or breast feeding&#xD;
&#xD;
          4. Second primary malignancy(except in situ carcinoma of the cervix or adequately treated&#xD;
             nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years&#xD;
             previously with no evidence of recurrence)&#xD;
&#xD;
          5. Documented parenchymal or leptomeningeal brain metastasis&#xD;
&#xD;
          6. Peripheral neuropathy ≥ grade 2&#xD;
&#xD;
          7. Prior treatment with gemcitabine will not be allowed.&#xD;
&#xD;
          8. HER-2 overexpressing breast cancer and concomitant trastuzumab treatment is not&#xD;
             allowed&#xD;
&#xD;
          9. Women of childbearing potential, unwilling to use a medically acceptable method of&#xD;
             contraception during the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyung Hae Jung, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Kyung Hae Jung</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>HER2-Negative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_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/NCT02263495
org study id: 2014-0857
nct id: NCT02263495
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective
      chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the
      preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a
      maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as shown
      in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin Oncol
      31(14):1732, 2013).

      Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival
      benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of
      anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011).
      Eribulin was also reported its promising efficacy in another randomized phase III study that
      demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS
      2012). Both study results showed potential clinical benefit in patients with triple negative
      MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for early
      line therapy in patients with metastatic breast cancer.

      Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of
      neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity
      profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in
      a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared
      to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG.

      In phase I trial, eribulin in combination with gemcitabine was feasible in patients with
      advanced solid tumor treated with chemotherapy (< 3 lines) (Goel R, et al, 2009 ASCO).

      Based on this rationale, the investigators are to conduct randomized phase II study comparing
      EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as first-line
      chemotherapy.

      A total of 118 patients will be recruited. Patients will be randomized to a treatment arm by
      permutated method. The randomization ratio is 1:1. This study is multi-center, randomized,
      open label study.
A total of enrolled 118 patients in EG and PG groups, will be provided chemotherapy regimen:

      Paclitaxel/Gemcitabine (PG) : every 3 weeks D1 Paclitaxel 175mg/m2 + D5W 500mL MIV over 3hrs
      before gemcitabine administration D1, D8 Gemcitabine 1,250 mg/m2 + NormalSaline 100ml MIV
      over 30mins

        -  Pre & Post medication (which can be changed according to institutions' policy) D1
           Corticosteroid 100 mg i.v. 30 min. before Paclitaxel Pheniramine 1A + D5W 50mL MIV
           30mins before Paclitaxel Ranitidine 50mg IV + D5W 50mL MIV 30mins before Paclitaxel HT3
           antagonist 1A + D5W 50 mL MIV 30mins before Paclitaxel

      Eribulin/Gemcitabine (EG): every 3weeks D1, D8 Eribulin 1.0 mg/m2, 2-5min iv before
      gemcitabine (or miv with NormalSaline 100ml in max.) D1, D8 Gemcitabine 1000 mg/m2 +
      NormalSaline100ml MIV over 30mins

      <schedule of Assessment adn procedures (±3 days window period ) >

        1. screening /baseline

             -  obtaining Informed consent form

             -  collecting information

             -  demographic data

             -  breast cancer treatment history/ medical history

             -  general physical examination/ vital sign & Performance status

             -  Test: CBC/blood chemistry/ Tumor response(CT or MRI)/

             -  collecting QOL questionnaire using FACT-Taxane

        2. cycle 1 ~ prior to EOT

             -  general physical examination/ vital sign & Performance status

             -  Test: CBC/blood chemistry/ Tumor response(CT or MRI)

             -  collecting QOL questionnaire using FACT-Taxane

             -  administration PG or EG

        3. EOT(end of treatment)

             -  general physical examination/ vital sign & Performance status

             -  Test: CBC/blood chemistry/ Tumor response(CT or MRI)

             -  collecting QOL questionnaire using FACT-Taxane

        4. survival follow up(every 12weeks)

             -  survival

             -  anti neoplastic therapy after end of treatment

             -  The tumor response will be performed every 12 (±2) weeks until disease progression

      <WITHDRAWAL OF SUBJECTS>

      Subjects may be withdrawn from the study (i.e. from any further study medication or study
      procedure) for the following reasons:

        -  At their own request

        -  If, in the investigator's opinion, continuation in the study would be detrimental to the
           subject's well-being

        -  In case of disease progression

        -  In case of unacceptable toxicity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
time frame: 48months
description: To demonstrate that EG is not inferior to PG group in terms of PFS in patients with metastatic or recurrent breast cancer as first-line treatment.
measure: overall survival
time frame: 48months
description: Survival will be measured as the time from randomization to the date of death.
measure: neuropathic scale
time frame: expected at 9week , expected at 24week
description: FACT for Taxane QOL assessment
measure: toxicity of study drugs
time frame: from first administration until 28 days after the last dose administration
description: Using CTCAE Version 4.0
measure: duration of response
time frame: 48months
description: using RECIEST version 1.1
measure: objective response rate
time frame: 48months
description: using RECIEST version 1.1
measure: clinical benefit rate
time frame: 48months
description: using RECIEST version 1.1
arm group label: Paclitaxel & Gemcitabine(PG)
arm group type: Active Comparator
description: Paclitaxel 175mg/m2 IV , Day1,every 3weeks Gemcitabine 1250mg/m2 IV ,Day1& Day8 every 3weeks
arm group label: Eribulin & Gemcitabine(EG)
arm group type: Experimental
description: Eribulin 1.0 mg/m2, 2-5min iv ,Day1& Day8 every 3weeks Gemcitabine 1,000 mg/m2 ,Day1& Day8 every 3weeks
intervention type: Drug
intervention name: Paclitaxel
description: 175mg/m2 + D5W 500mL MIV over 3hrs before gemcitabine administration
arm group label: Paclitaxel & Gemcitabine(PG)
other name: Genexol,
intervention type: Drug
intervention name: Eribulin
description: 1.0 mg/m2, 2-5min iv before gemcitabine (or miv with NS 100ml in max.)
arm group label: Eribulin & Gemcitabine(EG)
other name: Halaven,
intervention type: Drug
intervention name: Gemcitabine
description: PG:1250mg/m2 + NS 100ml MIV over 30mins EG:1000mg/m2 + NS 100ml MIV over 30mins
arm group label: Eribulin & Gemcitabine(EG)
arm group label: Paclitaxel & Gemcitabine(PG)
other name: Gemcit
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Kyung Hae Jung, Dr
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Kyung Hae Jung
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine