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/NCT05979220</url>
    </required_header>
    <id_info>
      <org_study_id>OBU-SC-BC-II-015</org_study_id>
      <nct_id>NCT05979220</nct_id>
    </id_info>
    <brief_title>Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy</brief_title>
    <official_title>A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shuangyue Liu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>West China Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole&#xD;
        in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after&#xD;
        first-line chemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>Phase 2</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 (PFS)</measure>
      <time_frame>Estimated up to 23 months</time_frame>
      <description>The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival 2(PFS2)</measure>
      <time_frame>Estimated up to 27-31 months</time_frame>
      <description>The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Overall Survival(OS)</measure>
      <time_frame>Estimated up to 5 years</time_frame>
      <description>OS was defined as the time from the first study treatment to the date of death from any cause</description>
    </other_outcome>
    <other_outcome>
      <measure>Objective Response Rate（ORR）</measure>
      <time_frame>Estimated up to 23 months</time_frame>
      <description>Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)</description>
    </other_outcome>
    <other_outcome>
      <measure>Clinical Benefit Rate (CBR)</measure>
      <time_frame>Estimated up to 23 months</time_frame>
      <description>The percentage of participants who received study treatment and evaluated the best overall efficacy according to RECIST 1.1 criteria as complete remission (CR), partial remission (PR), and disease stability (SD) ≥ 24 weeks.</description>
    </other_outcome>
    <other_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Estimated up to 23 months</time_frame>
      <description>Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD).</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient Reported Outcome (PRO)</measure>
      <time_frame>Estimated up to 5 years</time_frame>
      <description>Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse events (AEs)</measure>
      <time_frame>Estimated up to 5 years</time_frame>
      <description>The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">178</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Dalpiciclib combined with Letrozole</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dalpiciclib combined with Letrozole,28 days as one cycle.&#xD;
  Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.&#xD;
  Letrozole: 2.5mg, p.o., once a day, continuous administration.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dalpiciclib combined with Letrozole</intervention_name>
      <description>A multicenter, single arm, prospective Phase II clinical study</description>
      <arm_group_label>Dalpiciclib combined with Letrozole</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic,&#xD;
               hormone-receptor positive, HER2 negative Breast Cancer.&#xD;
  &#xD;
            2. Age: 18 - 75 years old&#xD;
  &#xD;
            3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1&#xD;
  &#xD;
            4. Functions of liver and kidney is normal&#xD;
  &#xD;
            5. Agreed to take contraceptive measures during treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Confirmed diagnosis of HER2 positive disease.&#xD;
  &#xD;
            2. Central nervous system metastasis&#xD;
  &#xD;
            3. Patients who received prior treatment with any CDK4/6 inhibitor.&#xD;
  &#xD;
            4. Clinically significant cardiovascular and cerebrovascular diseases,including but not&#xD;
               limited to severe acute myocardial infarction within 6 months before enrollment,&#xD;
               unstable or severe angina, Congestive heart failure (New York heart association (NYHA)&#xD;
               class &gt; 2), or ventricular arrhythmia which need medical intervention；&#xD;
  &#xD;
            5. Researchers believe that is not suitable for the study&#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_contact>
      <last_name>Ting Luo, post-doctor</last_name>
      <phone>18602866299</phone>
      <email>tina621@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiaorong Zhong, post-doctor</last_name>
      <phone>18980605984</phone>
      <email>zhongxiaorong@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>West China Hospital, Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ting Luo, MD</last_name>
        <phone>18602866299</phone>
        <phone_ext>+86</phone_ext>
        <email>tina621@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>West China Hospital</investigator_affiliation>
      <investigator_full_name>Shuangyue Liu</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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Letrozole</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/NCT05979220
  org study id: OBU-SC-BC-II-015
  nct id: NCT05979220
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole
        in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after
        first-line chemotherapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression Free Survival (PFS)
  time frame: Estimated up to 23 months
  description: The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.
  measure: Progression Free Survival 2(PFS2)
  time frame: Estimated up to 27-31 months
  description: The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause.
  measure: Overall Survival(OS)
  time frame: Estimated up to 5 years
  description: OS was defined as the time from the first study treatment to the date of death from any cause
  measure: Objective Response Rate（ORR）
  time frame: Estimated up to 23 months
  description: Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
  measure: Clinical Benefit Rate (CBR)
  time frame: Estimated up to 23 months
  description: The percentage of participants who received study treatment and evaluated the best overall efficacy according to RECIST 1.1 criteria as complete remission (CR), partial remission (PR), and disease stability (SD) ≥ 24 weeks.
  measure: Disease Control Rate (DCR)
  time frame: Estimated up to 23 months
  description: Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD).
  measure: Patient Reported Outcome (PRO)
  time frame: Estimated up to 5 years
  description: Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life
  measure: Adverse events (AEs)
  time frame: Estimated up to 5 years
  description: The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
  arm group label: Dalpiciclib combined with Letrozole
  arm group type: Experimental
  description: Dalpiciclib combined with Letrozole,28 days as one cycle.
  Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
  Letrozole: 2.5mg, p.o., once a day, continuous administration.
  intervention type: Drug
  intervention name: Dalpiciclib combined with Letrozole
  description: A multicenter, single arm, prospective Phase II clinical study
  arm group label: Dalpiciclib combined with Letrozole
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Ting Luo, post-doctor
  phone: 18602866299
  email: tina621@163.com
  last name: Xiaorong Zhong, post-doctor
  phone: 18980605984
  email: zhongxiaorong@126.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: West China Hospital
  investigator full name: Shuangyue Liu
  investigator title: Clinical Professor
  mesh term: Breast Neoplasms
  mesh term: Letrozole