<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/NCT02188693</url>
  </required_header>
  <id_info>
    <org_study_id>NLLY-01</org_study_id>
    <nct_id>NCT02188693</nct_id>
  </id_info>
  <brief_title>Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer</brief_title>
  <official_title>Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of our study is to evaluate whether gemcitabine as a single agent is&#xD;
      superior to observation in improving progression-free survival (PFS) in patients with&#xD;
      metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG&#xD;
      as their first-line treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>From randomization to disease progression</time_frame>
    <description>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS(progression free survival)</measure>
    <time_frame>time from the date of randomization until the date of disease progression，assessed up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS(progression free survival)</measure>
    <time_frame>the time from the date of randomization until the date of disease progression,assessed up to 3 years</time_frame>
    <description>PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death,assessed up to 3 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS(overall survival)</measure>
    <time_frame>the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years</time_frame>
    <description>the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years</description>
  </secondary_outcome>
  <other_outcome>
    <measure>QoL(quality of life)</measure>
    <time_frame>the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years</time_frame>
    <description>the time from enrollment to disease progression or the date of first documented death,whichever comes first,to observe the quality of life in participants,assessed up to 3 years</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">267</enrollment>
  <condition>Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer</condition>
  <condition>Gemcitabine</condition>
  <condition>Maintenance Chemotherapy</condition>
  <arm_group>
    <arm_group_label>Gemcitabine, Experimental</arm_group_label>
    <description>Gemcitabine 1250 mg/m2, IV on day 1 of 21 day cycle,with a follow up for every 12 weeks until disease progression or the date of first documented death from any cause</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <description>Observation for every 12 weeks until disease progression or the date of first documented death from any cause</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      2 ml blood sample is needed before enrollment.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with MBC exhibited disease control (complete response + partial response + stable&#xD;
        disease) with first-line PG and were randomly assigned to maintenance chemotherapy or&#xD;
        observation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically Confirmed Metastatic, or Recurrent Breast Cancer&#xD;
&#xD;
          -  Age over 18 Years&#xD;
&#xD;
          -  ECOG Performance Status 0-2&#xD;
&#xD;
          -  Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or&#xD;
             Non-Measurable Lesions, Who Are Candidates for Chemotherapy&#xD;
&#xD;
          -  Life Expectancy ≥ 3 Months&#xD;
&#xD;
          -  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;
          -  Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.&#xD;
&#xD;
          -  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;
          -  Prior Radiation Therapy Allowed as Long as &lt; 25% of the Bone Marrow Has Been&#xD;
             Treated,and the Patients Must Have Recovered From the Acute Toxic Effects of the&#xD;
             Treatment Prior to Study Enrollment.Prior Radiation to the Whole Pelvis is Not&#xD;
             Allowed. Prior Radiotherapy Must be Completed 4 Weeks Before Study Entry.&#xD;
&#xD;
          -  Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0&#xD;
             g/dl)&#xD;
&#xD;
          -  Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)&#xD;
&#xD;
          -  Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal&#xD;
             Limit)&#xD;
&#xD;
          -  No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer&#xD;
&#xD;
          -  Written Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious Uncontrolled Intercurrent Infections&#xD;
&#xD;
          -  Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease&#xD;
&#xD;
          -  Pregnancy or Breast Feeding&#xD;
&#xD;
          -  Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated&#xD;
             at Least 5 Years Previously With no Evidence of Recurrence)&#xD;
&#xD;
          -  Documented Parenchymal or Leptomeningeal Brain Metastasis&#xD;
&#xD;
          -  Peripheral Neuropathy ≥ Grade 2&#xD;
&#xD;
          -  Prior Treatment With Gemcitabine Will Not be Allowed.&#xD;
&#xD;
          -  HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not&#xD;
             Allowed&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Nanlin, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Nanlin, Ph.D</last_name>
    <phone>+86-137-0911-3279</phone>
    <email>nanlin-74@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chen Cong, Master</last_name>
    <phone>+86-136-4929-4730</phone>
    <email>congcongfeiyang@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xijing Hospital ， Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Nanlin, Ph.D</last_name>
      <phone>+86-137-0911-3279</phone>
      <email>nanlin-74@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Chen Cong, Master</last_name>
      <phone>+86-136-4929-4730</phone>
      <email>congcongfeiyang@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Li Nanlin, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>LiNanlin,Ph.D, Chief Physician,Clinical Professor</investigator_full_name>
    <investigator_title>The department of Vascular endocrine surgery</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>
  <!-- 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/NCT02188693
org study id: NLLY-01
nct id: NCT02188693
lead sponsor: 
collaborator: 
has dmc: No
The primary purpose of our study is to evaluate whether gemcitabine as a single agent is
      superior to observation in improving progression-free survival (PFS) in patients with
      metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG
      as their first-line treatment
observational model: Case-Control
time perspective: Prospective
measure: PFS
time frame: From randomization to disease progression
description: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
measure: PFS(progression free survival)
time frame: time from the date of randomization until the date of disease progression，assessed up to 3 years
measure: PFS(progression free survival)
time frame: the time from the date of randomization until the date of disease progression,assessed up to 3 years
description: PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death,assessed up to 3 years
measure: OS(overall survival)
time frame: the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years
description: the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years
measure: QoL(quality of life)
time frame: the time from enrollment to disease progression or the date of first documented death,assessed up to 3 years
description: the time from enrollment to disease progression or the date of first documented death,whichever comes first,to observe the quality of life in participants,assessed up to 3 years
arm group label: Gemcitabine, Experimental
description: Gemcitabine 1250 mg/m2, IV on day 1 of 21 day cycle,with a follow up for every 12 weeks until disease progression or the date of first documented death from any cause
arm group label: Observational
description: Observation for every 12 weeks until disease progression or the date of first documented death from any cause
2 ml blood sample is needed before enrollment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Li Nanlin, Ph.D
role: Study Director
affiliation: Air Force Military Medical University, China
last name: Li Nanlin, Ph.D
phone: +86-137-0911-3279
email: nanlin-74@163.com
last name: Chen Cong, Master
phone: +86-136-4929-4730
email: congcongfeiyang@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: LiNanlin,Ph.D, Chief Physician,Clinical Professor
investigator title: The department of Vascular endocrine surgery
mesh term: Breast Neoplasms