<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/NCT03775928</url>
  </required_header>
  <id_info>
    <org_study_id>LB</org_study_id>
    <nct_id>NCT03775928</nct_id>
  </id_info>
  <brief_title>Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer</brief_title>
  <official_title>Phase Ⅱ Study of Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
      The purpose of this study is to assess the efficacy and safety of patients who receive&#xD;
      apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with&#xD;
      advanced triple-negative breast cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy,&#xD;
      less treatment, and resistance to treatment. Advanced patients have shorter survival than&#xD;
      other subtypes. Maintenance therapy after combination chemotherapy can prolong the disease&#xD;
      control time in patients with advanced TNBC. How to prolong the disease control time of&#xD;
      patients with advanced TNBC without affecting the quality of life has become the focus of&#xD;
      current research.&#xD;
&#xD;
      Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some&#xD;
      efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows&#xD;
      significant antitumor activity in the patients with breast cancer. The results of this study&#xD;
      will help explore the new treatment of small molecule anti-angiogenic drugs for TNBC&#xD;
      maintenance therapy, and provide some new ideas for improving individualized treatment&#xD;
      options for patients with advanced TNBC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 18, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</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>up to 6 months</time_frame>
    <description>Time from randomization to disease progression or death for any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Time from randomization to death for any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tine to progress</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Time from randomization to disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Triple-negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib + Capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capecitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>capecitabine 1000mg/m2 bid d1-14, q21d</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>apatinib 425mg qd po</description>
    <arm_group_label>Apatinib + Capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>capecitabine</intervention_name>
    <description>capecitabine 1000mg/m2 bid d1-d14</description>
    <arm_group_label>Apatinib + Capecitabine</arm_group_label>
    <arm_group_label>Capecitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age：18~75 years;&#xD;
&#xD;
          2. Triple-negative breast cancer (TNBC) confirmed by histology examination;&#xD;
&#xD;
          3. patients had received first-line combination chemotherapy for advanced metastatic&#xD;
             disease, and had a complete response, partial response or stable disease according to&#xD;
             Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria;&#xD;
&#xD;
          4. received endocrine therapy for metastatic disease before first-line chemotherapy were&#xD;
             allowed;&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;&#xD;
&#xD;
          6. A life expectancy of more than 12 weeks;&#xD;
&#xD;
          7. Baseline blood routine examination in accordance with the following criteria :&#xD;
             ANC≥1.5×109/L，PLT≥90×109/L，Hb≥90g/L;&#xD;
&#xD;
          8. Liver and renal function in accordance with the following criteria: total bilirubin&#xD;
             less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST),&#xD;
             or alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value,&#xD;
             less than 5 times the upper limit of normal value in patients with liver metastases.&#xD;
&#xD;
             the creatinine clearance rate calculated greater than 60 mL/min;&#xD;
&#xD;
          9. Females of childbearing potential must be a pregnancy test in 7 days before&#xD;
             participating ( including serum or urine), and the results were negative, and they are&#xD;
             willing to take effective contraceptive methods During the trial and within 8 weeks&#xD;
             after the last dose;&#xD;
&#xD;
         10. Obtain informed consent from patients before starting any research-related operations&#xD;
             and treatments to confirm that patients are willing to participate in this study and&#xD;
             comply with research-related requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metastasis/recurrence occurs within 6 months of adjuvant chemotherapy;&#xD;
&#xD;
          2. controlled high blood pressure, systolic blood pressure ≥150mmHg or diastolic blood&#xD;
             pressure ≥100mmHg;&#xD;
&#xD;
          3. urine routine test with urinary protein more than ++, or 24 hour urinary protein more&#xD;
             than 1.0 g;&#xD;
&#xD;
          4. abnormal coagulation function (INR &gt; 1.5 or prothrombin time (PT) &gt; ULN+4 seconds or&#xD;
             APTT &gt;1.5 times the ULN);&#xD;
&#xD;
          5. Pregnant or lactating woman;&#xD;
&#xD;
          6. Symptomatic brain parenchymal and/or pia mater metastases without treatment and&#xD;
             control;&#xD;
&#xD;
          7. Patients with Other malignant tumors in the past 5 years, except for fully treated&#xD;
             cervical carcinoma in situ, cutaneous squamous cell carcinoma or well-controlled&#xD;
             localized basal cell skin cancer;&#xD;
&#xD;
          8. Mental illness or other condition that affects patient compliance;&#xD;
&#xD;
          9. serious and uncontrollable systemic diseases (eg clinically significant cardiovascular&#xD;
             disease, lung or metabolic disease, arteriovenous thrombosis, etc.) happened recently;&#xD;
&#xD;
         10. Can not take or absorb oral drugs;&#xD;
&#xD;
         11. Receiving any other testing drugs, or participating in other clinical trial 30 days&#xD;
             before being enrolled in this trial;&#xD;
&#xD;
         12. The patient has previously received treatment with an anti-angiogenic drug (whether&#xD;
             adjuvant or palliative);&#xD;
&#xD;
         13. Known or suspected to be allergic to any research drug or excipient;&#xD;
&#xD;
         14. Any other researcher believes that it is not appropriate to participate in this test.&#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>Binghe Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Binghe Xu</last_name>
    <phone>86-87788826</phone>
    <phone_ext>861087788120</phone_ext>
    <email>xubinghe@medmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bo Lan</last_name>
    <phone>86-87788114</phone>
    <phone_ext>861087788120</phone_ext>
    <email>daxiaolanbo@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer hospital, ChineseAMS</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Binghe Xu, PhD</last_name>
      <phone>86-10-87788826</phone>
      <email>xubinghe@medmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Bo Lan, PhD</last_name>
      <phone>86-10-87788114</phone>
      <email>daxiaolanbo@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Binghe Xu, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fei Ma, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bo Lan, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ma Fei，MD</investigator_full_name>
    <investigator_title>clinical professor</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>Capecitabine</mesh_term>
    <mesh_term>Apatinib</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/NCT03775928
org study id: LB
nct id: NCT03775928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the efficacy and safety of patients who receive
      apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with
      advanced triple-negative breast cancer
Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy,
      less treatment, and resistance to treatment. Advanced patients have shorter survival than
      other subtypes. Maintenance therapy after combination chemotherapy can prolong the disease
      control time in patients with advanced TNBC. How to prolong the disease control time of
      patients with advanced TNBC without affecting the quality of life has become the focus of
      current research.

      Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some
      efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows
      significant antitumor activity in the patients with breast cancer. The results of this study
      will help explore the new treatment of small molecule anti-angiogenic drugs for TNBC
      maintenance therapy, and provide some new ideas for improving individualized treatment
      options for patients with advanced TNBC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression-free survival
time frame: up to 6 months
description: Time from randomization to disease progression or death for any cause
measure: overall survival
time frame: up to 6 months
description: Time from randomization to death for any cause
measure: tine to progress
time frame: up to 6 months
description: Time from randomization to disease progression
measure: Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: up to 6 months
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
arm group label: Apatinib + Capecitabine
arm group type: Experimental
description: Apatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d
arm group label: Capecitabine
arm group type: Active Comparator
description: capecitabine 1000mg/m2 bid d1-14, q21d
intervention type: Drug
intervention name: Apatinib
description: apatinib 425mg qd po
arm group label: Apatinib + Capecitabine
intervention type: Drug
intervention name: capecitabine
description: capecitabine 1000mg/m2 bid d1-d14
arm group label: Apatinib + Capecitabine
arm group label: Capecitabine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Binghe Xu
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Binghe Xu
phone: 86-87788826
phone ext: 861087788120
email: xubinghe@medmail.com
last name: Bo Lan
phone: 86-87788114
phone ext: 861087788120
email: daxiaolanbo@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Ma Fei，MD
investigator title: clinical professor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Capecitabine
mesh term: Apatinib
sharing ipd: No