<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/NCT03254654</url>
  </required_header>
  <id_info>
    <org_study_id>Fudan BR2017-23</org_study_id>
    <nct_id>NCT03254654</nct_id>
  </id_info>
  <brief_title>Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer</brief_title>
  <official_title>A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN Trail)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</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>
      Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine&#xD;
      as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast&#xD;
      Cancer (NAN trail)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>PFS</measure>
    <time_frame>6 weeks</time_frame>
    <description>Progression Free Survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
    <description>Overall Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>6 weeks</time_frame>
    <description>Objective Response Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Number of Participants with Adverse Events</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Advanced Triple-Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Vinorelbine Plus Apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vinorelbine: 20 mg/m2, D6, D13, D20&#xD;
Apatinib: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 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, D1, D8, D15</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <description>Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15</description>
    <arm_group_label>Vinorelbine</arm_group_label>
    <arm_group_label>Vinorelbine Plus Apatinib</arm_group_label>
    <other_name>NVB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.</description>
    <arm_group_label>Vinorelbine Plus Apatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Performance Status 0-1&#xD;
&#xD;
          2. Life expectancy longer than 3 months&#xD;
&#xD;
          3. Histological proven unresectable recurrent or advanced breast cancer&#xD;
&#xD;
          4. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human&#xD;
             epithelial receptor-2 (HER2) by immunohistochemistry (ER &lt;1%, PR &lt;1% and Her2&#xD;
             negative). A negative Her2 gene amplification should be verified by FISH test for&#xD;
             those patients with Her2 (2+)&#xD;
&#xD;
          5. Patients must have progressed after 1 or 2 prior chemotherapy regimens for metastatic&#xD;
             disease, and consistent with the following treatment failure definition: progress in&#xD;
             the first-line or second-line regimen treatment, or follow-up disease progression less&#xD;
             than 3 months after completion of their last dose&#xD;
&#xD;
          6. At least one extracranial measurable disease according to the response evaluation&#xD;
             criteria in solid tumor (RECIST 1.1)&#xD;
&#xD;
          7. Radiation therapy within 4 weeks prior to enrollment&#xD;
&#xD;
          8. All patients enrolled are required to have adequate hematologic, hepatic, and renal&#xD;
             function&#xD;
&#xD;
          9. Be able to understand the study procedures and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients had prior treatment with vinorelbine&#xD;
&#xD;
          2. Pregnant or lactating women, women of child-bearing potential, unwilling to use&#xD;
             adequate contraceptive protection during the process of the study&#xD;
&#xD;
          3. Patients with symptomatic central nervous system metastases are not permitted, except&#xD;
             for those with stable and asymptomatic brain metastases who have completed cranial&#xD;
             irradiation, and have at least one measurable lesion outside the brain. Radiotherapy&#xD;
             should be completed within 4 weeks prior to the registration&#xD;
&#xD;
          4. Treatment with an investigational product within 4 weeks before the first treatment&#xD;
&#xD;
          5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction&#xD;
&#xD;
          6. Uncontrolled serious infection&#xD;
&#xD;
          7. Unhealed wound or bone fracture&#xD;
&#xD;
          8. Patients with hypertension and uncontrolled hypertension with hypotensive drugs&#xD;
             therapy (systolic blood pressure &gt; 140 mmHg, diastolic blood pressure &gt; 90 mmHg).&#xD;
             Patients with grade I or above myocardial ischemia or myocardial infarction or&#xD;
             arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency&#xD;
&#xD;
          9. Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of&#xD;
             the intestine, various factors which affect drug use and absorption&#xD;
&#xD;
         10. Coagulation disorders (PT &gt; 16 s, APTT &gt; 43 s, TT &gt; 21 s, Fbg &lt; 2g / L) Being treated&#xD;
             with thrombolytic or anticoagulant therapy, with bleeding tendency or definite&#xD;
             gastrointestinal bleeding concerns (eg: local active ulcer lesions, fecal occult blood&#xD;
             + + or above)&#xD;
&#xD;
         11. Artery or venous thrombosis occurred within 6 months before the study begins, such as&#xD;
             cerebrovascular accident (including transient ischemic attack), deep vein thrombosis,&#xD;
             and pulmonary embolism, etc.&#xD;
&#xD;
         12. Patient who has a history of psychotropic substance abuse and is unable to stop or&#xD;
             have a history of mental disorders&#xD;
&#xD;
         13. Have received prior treatment with a VEGFR TKI (Bevacizumab is permitted)&#xD;
&#xD;
         14. Another malignancy within 5 years, except for cured basal cell carcinoma of the skin&#xD;
             and cervical carcinoma&#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>Xichun Hu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xichun Hu</investigator_full_name>
    <investigator_title>Vice Director of department of medical oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
    <mesh_term>Vinorelbine</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/NCT03254654
org study id: Fudan BR2017-23
nct id: NCT03254654
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine
      as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast
      Cancer (NAN trail)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: 6 weeks
description: Progression Free Survival
measure: OS
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
description: Overall Survival
measure: ORR
time frame: 6 weeks
description: Objective Response Rate
measure: Safety: Number of Participants with Adverse Events
time frame: 6 weeks
description: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
arm group label: Vinorelbine Plus Apatinib
arm group type: Experimental
description: Vinorelbine: 20 mg/m2, D6, D13, D20
Apatinib: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
arm group label: Vinorelbine
arm group type: Active Comparator
description: Vinorelbine: 25 mg/m2, D1, D8, D15
intervention type: Drug
intervention name: Vinorelbine
description: Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15
arm group label: Vinorelbine
arm group label: Vinorelbine Plus Apatinib
other name: NVB
intervention type: Drug
intervention name: Apatinib
description: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
arm group label: Vinorelbine Plus Apatinib
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xichun Hu, MD, PhD
role: Principal Investigator
affiliation: Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Xichun Hu
investigator title: Vice Director of department of medical oncology
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Apatinib
mesh term: Vinorelbine