<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/NCT03242616</url>
  </required_header>
  <id_info>
    <org_study_id>H1607-172-780</org_study_id>
    <nct_id>NCT03242616</nct_id>
  </id_info>
  <brief_title>PemVin vs Vin in Previously Treated Metastatic Breast Cancer</brief_title>
  <official_title>Randomized Phase II Trial of Pemetrexed Plus Vinorelbine Versus Vinorelbine in Patients With Recurrent or Metastatic Breast Cancer Previously Treated With or Resistant to Anthracycline and Taxane</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and&#xD;
      mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these&#xD;
      are largely done before the wide use of premedication (steroid and vitamin B12) for&#xD;
      pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a&#xD;
      commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.&#xD;
&#xD;
      This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in&#xD;
      patients with recurrent or metastatic breast cancer previously treated with or resistant to&#xD;
      an anthracycline and taxane.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>response assessment every 6 weeks, for up to 2 years</time_frame>
    <description>From date of first dose of study drug till the date of documented progression or death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>response rate</measure>
    <time_frame>response assessment every 6 weeks, for up to 2 years</time_frame>
    <description>Proportion of patients with objective response by RECIST version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of response</measure>
    <time_frame>response assessment every 6 weeks, for up to 2 years</time_frame>
    <description>Time from documentation of tumor response to disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>up to 2 years</time_frame>
    <description>From date of first dose of study drug till the date of death from any cause</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Pemetrexed + Vinorelbine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vinorelbine (25 mg/m2, day 1 &amp; 8)&#xD;
Pemetrexed (500 mg/m2, day 1)&#xD;
Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th…. cycle after then.)&#xD;
Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose&#xD;
Dexa 4mg po bid on D0-2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vinorelbine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vinorelbine (25 mg/m2, day 1 &amp; 8)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed + Vinorelbine</intervention_name>
    <description>Vinorelbine (25 mg/m2, day 1 &amp; 8)&#xD;
Pemetrexed (500 mg/m2, day 1)</description>
    <arm_group_label>Pemetrexed + Vinorelbine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <description>Vinorelbine (25 mg/m2, day 1 &amp; 8)</description>
    <arm_group_label>Vinorelbine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. histologically confirmed, recurrent or metastatic breast cancer&#xD;
&#xD;
          2. HER2-negative&#xD;
&#xD;
          3. ECOG PS 0-2&#xD;
&#xD;
          4. Age ≥ 20 years&#xD;
&#xD;
          5. Anthracycline- and Taxane-pretreated&#xD;
&#xD;
          6. Wash-out period of 3 weeks for cytotoxic chemotherapy&#xD;
&#xD;
          7. Wash-out period of 2 weeks for hormone therapy or radiotherapy&#xD;
&#xD;
          8. measurable or non-measurable lesions by RECIST v1.1&#xD;
&#xD;
          9. Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL&#xD;
&#xD;
         10. Adequate liver functions&#xD;
&#xD;
         11. Adequate renal functions : sCr≤1.5mg/dL&#xD;
&#xD;
         12. Subjects willing to follow study protocol&#xD;
&#xD;
         13. Informed consent before study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. More than 3 lines of chemotherapy for metastatic breast cancer&#xD;
&#xD;
          2. Pregnant or breastfeeding women&#xD;
&#xD;
          3. Previous exposure to Pemetrexed or Vinorelbine&#xD;
&#xD;
          4. Neuropathy (grade 2 or more)&#xD;
&#xD;
          5. Symptomatic CNS metastasis&#xD;
&#xD;
          6. History of malignant disease within 5 years (except for cured basal cell cancer or&#xD;
             squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer)&#xD;
&#xD;
          7. Hypersensitivity to study medication or related drugs&#xD;
&#xD;
          8. Concomitant vaccination for yellow fever&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Seock-Ah Im</last_name>
    <phone>82-2-2072-0850</phone>
    <email>moisa@snu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kyung-Hun Lee</last_name>
    <phone>82-2-2072-7207</phone>
    <email>kyunghunlee@snu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seock-Ah Im</last_name>
      <phone>82-2-2072-0850</phone>
      <email>moisa@snu.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Seock-Ah Im</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Pemetrexed</mesh_term>
    <mesh_term>Vinorelbine</mesh_term>
  </intervention_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/NCT03242616
org study id: H1607-172-780
nct id: NCT03242616
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and
      mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these
      are largely done before the wide use of premedication (steroid and vitamin B12) for
      pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a
      commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.

      This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in
      patients with recurrent or metastatic breast cancer previously treated with or resistant to
      an anthracycline and taxane.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: response assessment every 6 weeks, for up to 2 years
description: From date of first dose of study drug till the date of documented progression or death from any cause
measure: response rate
time frame: response assessment every 6 weeks, for up to 2 years
description: Proportion of patients with objective response by RECIST version 1.1
measure: duration of response
time frame: response assessment every 6 weeks, for up to 2 years
description: Time from documentation of tumor response to disease progression
measure: overall survival
time frame: up to 2 years
description: From date of first dose of study drug till the date of death from any cause
arm group label: Pemetrexed + Vinorelbine
arm group type: Experimental
description: Vinorelbine (25 mg/m2, day 1 & 8)
Pemetrexed (500 mg/m2, day 1)
Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th…. cycle after then.)
Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose
Dexa 4mg po bid on D0-2
arm group label: Vinorelbine
arm group type: Active Comparator
description: Vinorelbine (25 mg/m2, day 1 & 8)
intervention type: Drug
intervention name: Pemetrexed + Vinorelbine
description: Vinorelbine (25 mg/m2, day 1 & 8)
Pemetrexed (500 mg/m2, day 1)
arm group label: Pemetrexed + Vinorelbine
intervention type: Drug
intervention name: Vinorelbine
description: Vinorelbine (25 mg/m2, day 1 & 8)
arm group label: Vinorelbine
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Seock-Ah Im
phone: 82-2-2072-0850
email: moisa@snu.ac.kr
last name: Kyung-Hun Lee
phone: 82-2-2072-7207
email: kyunghunlee@snu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Seock-Ah Im
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Pemetrexed
mesh term: Vinorelbine
sharing ipd: No