<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/NCT02253459</url>
  </required_header>
  <id_info>
    <org_study_id>BG01-1323L</org_study_id>
    <nct_id>NCT02253459</nct_id>
  </id_info>
  <brief_title>Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer</brief_title>
  <official_title>Phase III Clinical Trials of UTD1 Injection Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced and Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Biostar Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Biostar Pharmaceuticals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether UTD1 Injection in combination with&#xD;
      capecitabine is effective in the treatment of advanced metastatic breast cancer using&#xD;
      capecitabine as a control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 15, 2018</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 3</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>Progresssion free survival (PFS)</measure>
    <time_frame>2.0 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate(ORR）</measure>
    <time_frame>1.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">405</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>UTD1 Injection plus capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UTD1 Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle; Capecitabine: 2000 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle.&#xD;
Number of Cycles: until progression or unacceptable toxicity develops.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>capecitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capecitabine: 2500 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle.&#xD;
Number of Cycles: until progression or unacceptable toxicity develops.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UTD1 Injection plus capecitabine</intervention_name>
    <arm_group_label>UTD1 Injection plus capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <arm_group_label>capecitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically and/or cytologically diagnosed patients with advanced, metastatic&#xD;
             breast cancer,or lacking standard therapy or being failed to or recurrent after&#xD;
             standard therapy;&#xD;
&#xD;
          2. Patients who have previously treated with ≤4 chemotherapeutic regimes;&#xD;
&#xD;
          3. Patients who have previously treated with an anthracyclin antibiotics and a taxane;&#xD;
&#xD;
          4. Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or&#xD;
             more;&#xD;
&#xD;
          5. Patients with at least 1 measurable target lesion determined by CT within 2 weeks&#xD;
             prior to enrollment;&#xD;
&#xD;
          6. Neuropathy &lt;CTC2 degree （NCI CTC4.03）within 4 weeks prior to enrollment;&#xD;
&#xD;
          7. Basically normal results from routine blood test within 1 week prior to enrollment;&#xD;
&#xD;
          8. Basically normal liver and renal functions within 1 week prior to enrollment;&#xD;
&#xD;
          9. No abnormal function for major internal organs, no heart diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted&#xD;
             drugs 4 weeks prior to enrollment, or received other chemotherapies while&#xD;
             participating in this trial;&#xD;
&#xD;
          2. Patients with documented hypersensitivity to Cremophor EL, or patients with previous&#xD;
             taxane treatment related SAE;&#xD;
&#xD;
          3. Patients of pregnancy or breast feeding;&#xD;
&#xD;
          4. Patients with previous standard capecitabine treatment ineffective, or patients&#xD;
             received standard capecitabine treatment effective, but with less than 6 months of&#xD;
             capecitabine clearance period;&#xD;
&#xD;
          5. Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent&#xD;
             surgery or local radiotherapy, or other emergency treatment;&#xD;
&#xD;
          6. Patients combined with severe and /or uncontrolled medical conditions, including&#xD;
             severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe&#xD;
             infection, severe gastrointestinal ulceration, and patients with incontrollable&#xD;
             psychiatric history;&#xD;
&#xD;
          7. Patients with poor compliance;&#xD;
&#xD;
          8. Patients not fitted for this study determined by the investigators.&#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>B Xu, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital Affiliated To Military Medical Science</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The General Hospital of the People's Liberation Army</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>April 5, 2019</last_update_submitted>
  <last_update_submitted_qc>April 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Capecitabine</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/NCT02253459
org study id: BG01-1323L
nct id: NCT02253459
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether UTD1 Injection in combination with
      capecitabine is effective in the treatment of advanced metastatic breast cancer using
      capecitabine as a control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progresssion free survival (PFS)
time frame: 2.0 years
measure: Overall survival (OS)
time frame: 4 years
measure: Objective Response Rate(ORR）
time frame: 1.5 years
arm group label: UTD1 Injection plus capecitabine
arm group type: Experimental
description: UTD1 Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle; Capecitabine: 2000 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
arm group label: capecitabine
arm group type: Active Comparator
description: Capecitabine: 2500 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
intervention type: Drug
intervention name: UTD1 Injection plus capecitabine
arm group label: UTD1 Injection plus capecitabine
intervention type: Drug
intervention name: Capecitabine
arm group label: capecitabine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: B Xu, doctor
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Capecitabine