xml: <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/NCT06015126</url>
    </required_header>
    <id_info>
      <org_study_id>Y-pierrefabre202102-0108</org_study_id>
      <nct_id>NCT06015126</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients</brief_title>
    <official_title>Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yan Xue</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xi'an International Medical Center 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>
        vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast&#xD;
        cancer. It is available in oral form, making it convenient to use and an ideal choice for&#xD;
        rhythmic chemotherapy. In advanced breast cancer,metronomic oral vinorelbine chemotherapy has&#xD;
        been the subject of several clinical studies, with proven effectiveness and good safety,&#xD;
        showing great prospects for application.&#xD;
  &#xD;
        Considering the current lack of targeted, efficient, and convenient drugs for HER2-negative&#xD;
        advanced breast cancer in later lines of treatment, and based on the preliminary efficacy of&#xD;
        metronomic oral vinorelbine, anlotinib, and rhythmic chemotherapy in breast cancer, we plan&#xD;
        to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with&#xD;
        anlotinib in the treatment of HER2-negative advanced breast cancer, providing new data for&#xD;
        the treatment of HER2-negative advanced breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research Title A single-center, open-label, single-arm clinical study on the efficacy and&#xD;
        safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative&#xD;
        advanced breast cancer.&#xD;
  &#xD;
        Study Drugs - metronomic oral vinorelbine: 30mg/capsule, 20mg/capsule - Anlotinib:&#xD;
        12mg/capsule, 10mg/capsule, 8mg/capsule&#xD;
  &#xD;
        Research Objective To determine the efficacy and safety of metronomic oral vinorelbine&#xD;
        chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast&#xD;
        cancer, and to provide new data for later-line treatment of HER2-negative advanced breast&#xD;
        cancer.&#xD;
  &#xD;
        Study Design A single-center, open-label, single-arm clinical study with a planned enrollment&#xD;
        of 60 patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 5, 2022</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group 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>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>It is an indicator of the long-term efficacy of the drug.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate</measure>
      <time_frame>4 weeks</time_frame>
      <description>The proportion of patients with the best response of complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate</measure>
      <time_frame>4 weeks</time_frame>
      <description>The proportion of patients with tumor shrinkage or stability maintained for a certain period, including cases of CR, PR, and stable disease (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</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>It is an indicator of the long-term efficacy of the drug.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Label 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>metronomic oral vinorelbine plus anlotinib</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>metronomic oral vinorelbine plus anlotinib</intervention_name>
      <description>To clarify the efficacy and safety of metronomic oral vinorelbine plus anlotinib in HER2-negative metastatic breast cancer patients, adding new data for the posterior treatment of HER2-negative advanced breast cancer</description>
      <arm_group_label>Label 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria：&#xD;
  &#xD;
            -  Voluntarily sign an informed consent form;&#xD;
  &#xD;
            -  Females aged 18 years or older;&#xD;
  &#xD;
            -  ECOG physical performance status score of 0-2;&#xD;
  &#xD;
            -  Histologically confirmed HER2-negative metastatic breast cancer patients, and patients&#xD;
               with locally recurrent disease who cannot undergo curative surgery or radiation&#xD;
               therapy;&#xD;
  &#xD;
            -  HR-positive/HER2-negative advanced breast cancer patients who have primary endocrine&#xD;
               resistance or disease progression after first-line endocrine ± targeted therapy;&#xD;
  &#xD;
            -  Triple-negative advanced breast cancer patients with disease progression after&#xD;
               first-line chemotherapy ± immunotherapy;&#xD;
  &#xD;
            -  Blood routine examination meets the following conditions: ①absolute neutrophil count&#xD;
               (ANC) ≥1.5×10^9/L, ② platelets ≥100×10^9/L, ③ hemoglobin ≥90 g/L, ④ white blood cell&#xD;
               count ≥3.0×10^9/L;&#xD;
  &#xD;
            -  The liver function meets the following criteria: ① serum total bilirubin ≤ 1.5 × ULN,&#xD;
               and if there is liver metastasis, it should be ≤ 3 × ULN; ② AST or ALT ≤ 3 × ULN, and&#xD;
               if there is liver metastasis, it should be ≤ 5 × ULN;&#xD;
  &#xD;
            -  The renal function meets the following criteria: serum creatinine ≤ 1.5 × ULN or&#xD;
               creatinine clearance ≥ 50 mL/min (calculated according to the Cockroft-Gault formula);&#xD;
  &#xD;
            -  Female patients who meet the following criteria can participate in this study: ①&#xD;
               Patients are not capable of reproduction; ② Patients have reproductive capacity, and&#xD;
               have a negative result on the pregnancy test within 7 days before the first&#xD;
               administration of the investigational drug, are not in the lactation period, and&#xD;
               continuously adopt effective contraceptive measures before entering the study and&#xD;
               during the entire study period and within 6 months after the last administration of&#xD;
               the investigational drug.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have previously received treatment with vinorelbine and/or anlotinib;&#xD;
  &#xD;
            -  Patients with active or untreated brain metastasis;&#xD;
  &#xD;
            -  Patients who have had or currently have other malignancies within 5 years, except for&#xD;
               cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder&#xD;
               tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades&#xD;
               basement membrane)];&#xD;
  &#xD;
            -  Patients who have undergone major surgery (including thoracotomy biopsy) or suffered a&#xD;
               significant trauma (such as bone fracture) within 4 weeks before randomization, have&#xD;
               unhealed wounds or fractures at the time of screening, or are expected to undergo&#xD;
               major surgery during the study period;&#xD;
  &#xD;
            -  Patients with a history of myocardial infarction within the past 6 months; history of&#xD;
               congestive heart failure with New York Heart Association (NYHA) classification ≥ II,&#xD;
               or severe arrhythmia (excluding atrial fibrillation and paroxysmal supraventricular&#xD;
               tachycardia) that cannot be controlled by medication;&#xD;
  &#xD;
            -  Patients with known allergies to the drugs and their excipients involved in this&#xD;
               trial;&#xD;
  &#xD;
            -  Patients with a known history of hypersensitivity reactions to any investigational&#xD;
               drugs;&#xD;
  &#xD;
            -  Patients who are simultaneously participating in other trials;&#xD;
  &#xD;
            -  Patients who cannot evaluate the efficacy of the treatment plan with existing&#xD;
               technology;&#xD;
  &#xD;
            -  Patients judged unsuitable for participation by other investigators.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yan Xue</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xi'an International Medical Center Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yan Xue</last_name>
      <phone>0086-13992830596</phone>
      <email>1410605462@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xi'an International Medical Center Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710100</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yan Xue</last_name>
        <phone>0086-13992830596</phone>
        <email>1410605462@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Xi'an International Medical Center Hospital</investigator_affiliation>
      <investigator_full_name>Yan Xue</investigator_full_name>
      <investigator_title>Director of tumor hospital</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>Vinorelbine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015126
  org study id: Y-pierrefabre202102-0108
  nct id: NCT06015126
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast
        cancer. It is available in oral form, making it convenient to use and an ideal choice for
        rhythmic chemotherapy. In advanced breast cancer,metronomic oral vinorelbine chemotherapy has
        been the subject of several clinical studies, with proven effectiveness and good safety,
        showing great prospects for application.
  
        Considering the current lack of targeted, efficient, and convenient drugs for HER2-negative
        advanced breast cancer in later lines of treatment, and based on the preliminary efficacy of
        metronomic oral vinorelbine, anlotinib, and rhythmic chemotherapy in breast cancer, we plan
        to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with
        anlotinib in the treatment of HER2-negative advanced breast cancer, providing new data for
        the treatment of HER2-negative advanced breast cancer.
  Research Title A single-center, open-label, single-arm clinical study on the efficacy and
        safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative
        advanced breast cancer.
  
        Study Drugs - metronomic oral vinorelbine: 30mg/capsule, 20mg/capsule - Anlotinib:
        12mg/capsule, 10mg/capsule, 8mg/capsule
  
        Research Objective To determine the efficacy and safety of metronomic oral vinorelbine
        chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast
        cancer, and to provide new data for later-line treatment of HER2-negative advanced breast
        cancer.
  
        Study Design A single-center, open-label, single-arm clinical study with a planned enrollment
        of 60 patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression-Free Survival
  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: It is an indicator of the long-term efficacy of the drug.
  measure: Objective Response Rate
  time frame: 4 weeks
  description: The proportion of patients with the best response of complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  measure: Disease Control Rate
  time frame: 4 weeks
  description: The proportion of patients with tumor shrinkage or stability maintained for a certain period, including cases of CR, PR, and stable disease (SD).
  measure: Overall survival
  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: It is an indicator of the long-term efficacy of the drug.
  arm group label: Label 1
  arm group type: Experimental
  description: metronomic oral vinorelbine plus anlotinib
  intervention type: Drug
  intervention name: metronomic oral vinorelbine plus anlotinib
  description: To clarify the efficacy and safety of metronomic oral vinorelbine plus anlotinib in HER2-negative metastatic breast cancer patients, adding new data for the posterior treatment of HER2-negative advanced breast cancer
  arm group label: Label 1
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yan Xue
  role: Principal Investigator
  affiliation: Xi'an International Medical Center Hospital
  last name: Yan Xue
  phone: 0086-13992830596
  email: 1410605462@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Xi'an International Medical Center Hospital
  investigator full name: Yan Xue
  investigator title: Director of tumor hospital
  mesh term: Breast Neoplasms
  mesh term: Vinorelbine