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/NCT06033287</url>
    </required_header>
    <id_info>
      <org_study_id>KYJJ-2023-095</org_study_id>
      <nct_id>NCT06033287</nct_id>
    </id_info>
    <brief_title>Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.</brief_title>
    <official_title>Observational Real-World Study on the Efficacy, Safety, and Biomarker Exploration of CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- Metastatic Breast Cancer.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hunan Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hunan Cancer 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>
        Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4/6i&#xD;
        Progression in the Real World has significant implications. This study is an observational,&#xD;
        real-world study. It plans to include over 300 eligible HR+/HER2- metastatic breast cancer&#xD;
        patients who are currently receiving or planning to receive endocrine therapy regimens&#xD;
        containing CDK4/6 inhibitors. This study is a single-arm, non-interventional study that&#xD;
        evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4/6&#xD;
        inhibitors combined with endocrine therapy, based on clinical guideline consensus. After&#xD;
        disease progression on first-line treatment, the second-line systemic treatment regimen&#xD;
        (including but not limited to switching to another CDK4/6 inhibitor combined with endocrine&#xD;
        therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be&#xD;
        chosen by the physician, and the efficacy and safety of subsequent treatment will be&#xD;
        evaluated. Additionally, peripheral blood ctDNA testing will be used to assess changes in&#xD;
        baseline and progression-related biomarkers, including ESR1, PI3KCA, FGFR1, PTEN, among some&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </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 36 months</time_frame>
      <description>The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 36 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate</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 36 months</time_frame>
      <description>It is a statistical measure used in clinical trials to evaluate the effectiveness of a treatment by assessing the proportion of patients who achieve either a partial or complete objective response to the treatment.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Overall survival</measure>
      <time_frame>The time from randomization to death from any cause, whichever came first, assessed up to 36 months</time_frame>
      <description>The time from randomization to death from any cause</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse Events</measure>
      <time_frame>Primary Outcome Measure: 1.Progression-Free Survival The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months [Time Frame: From date of randomizatio</time_frame>
      <description>All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Endocrine Therapy</condition>
    <condition>CDK4/6 Inhibitors</condition>
    <condition>Subsequent Treatment</condition>
    <arm_group>
      <arm_group_label>CDK4/6 inhibitors treatment</arm_group_label>
      <description>All HR+/HER2- metastatic breast cancer patients using CDK4/6 inhibitors</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Different treatment regimens following progression on CDK4/6 inhibitors.</intervention_name>
      <description>This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4/6 inhibitors combined with endocrine therapy. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4/6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be evaluated.</description>
      <arm_group_label>CDK4/6 inhibitors treatment</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          HR+/HER2- metastatic breast cancer patients who are currently receiving or planning to&#xD;
          receive endocrine therapy regimens containing CDK4/6 inhibitors.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion criteria:&#xD;
  &#xD;
                 -  Age ≥ 18 years, postmenopausal or pre/perimenopausal females, or male patients.&#xD;
                    Female patients must meet one of the following criteria:&#xD;
  &#xD;
                      1. Prior bilateral oophorectomy or age ≥ 60 years.&#xD;
  &#xD;
                      2. Age &lt; 60 with natural postmenopausal status (defined as spontaneous&#xD;
                         cessation of regular menstruation for at least 12 consecutive months without&#xD;
                         any other pathological or physiological reasons), and estradiol (E2) and&#xD;
                         follicle-stimulating hormone (FSH) levels consistent with postmenopausal&#xD;
                         range.&#xD;
  &#xD;
                      3. Pre/perimenopausal females may also be eligible but must be willing to&#xD;
                         receive LHRH agonist during the study.&#xD;
  &#xD;
                 -  Pathologically confirmed HR-positive male/female breast cancer patients with&#xD;
                    evidence of localized recurrence or metastasis, who are not suitable for curative&#xD;
                    surgery or radiation therapy:&#xD;
  &#xD;
          ER-positive and/or PR-positive defined as the proportion of positively stained tumor cells&#xD;
          ≥ 1% of all tumor cells (as confirmed by the investigators at the participating center).&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.&#xD;
  &#xD;
            -  No prior systemic treatment or currently receiving CDK4/6 inhibitors as first-line&#xD;
               treatment for advanced disease.&#xD;
  &#xD;
            -  Reproductive-age females must have a negative serum pregnancy test within 28 days&#xD;
               before enrollment and male/female patients must be willing to use a medically approved&#xD;
               highly effective contraceptive measure during the study period and up to 1 year after&#xD;
               the last dose of investigational drug.&#xD;
  &#xD;
            -  Non-pregnant or non-lactating females.&#xD;
  &#xD;
            -  Not concurrently participating in any other ongoing study.&#xD;
  &#xD;
            -  Patient or legally authorized representative has provided informed consent and is&#xD;
               willing and able to comply with the planned visits, study treatment plan, laboratory&#xD;
               tests, and other trial procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Any evidence of severe or uncontrolled systemic illnesses, including uncontrolled&#xD;
               hypertension, active bleeding disorders, active infections including hepatitis B,&#xD;
               hepatitis C, and human immunodeficiency virus, or severely impaired bone marrow&#xD;
               reserve or organ function, including liver and kidney impairment, which, in the&#xD;
               investigator's opinion, would greatly alter the risk/benefit balance.&#xD;
  &#xD;
            -  Patient has not yet recovered from any CTCAE grade ≥ 3 toxicity related to prior&#xD;
               treatment at the start of CDK4/6 inhibitor therapy.&#xD;
  &#xD;
            -  Known history of allergy to CDK4/6 inhibitors, excipients, or drugs with a similar&#xD;
               chemical structure or class as CDK4/6 inhibitors.&#xD;
  &#xD;
            -  Patients deemed unsuitable for enrollment by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ning Xie, Dr.</last_name>
      <phone>+860731-89762161</phone>
      <email>xiening@hnca.org.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ting Liu, Ms.</last_name>
      <phone>+860731-89762815</phone>
      <email>liuting@hnca.org.cn</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06033287
  org study id: KYJJ-2023-095
  nct id: NCT06033287
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4/6i
        Progression in the Real World has significant implications. This study is an observational,
        real-world study. It plans to include over 300 eligible HR+/HER2- metastatic breast cancer
        patients who are currently receiving or planning to receive endocrine therapy regimens
        containing CDK4/6 inhibitors. This study is a single-arm, non-interventional study that
        evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4/6
        inhibitors combined with endocrine therapy, based on clinical guideline consensus. After
        disease progression on first-line treatment, the second-line systemic treatment regimen
        (including but not limited to switching to another CDK4/6 inhibitor combined with endocrine
        therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be
        chosen by the physician, and the efficacy and safety of subsequent treatment will be
        evaluated. Additionally, peripheral blood ctDNA testing will be used to assess changes in
        baseline and progression-related biomarkers, including ESR1, PI3KCA, FGFR1, PTEN, among some
        patients.
  observational model: Cohort
  time perspective: Prospective
  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 36 months
  description: The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 36 months
  measure: Objective Response Rate
  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 36 months
  description: It is a statistical measure used in clinical trials to evaluate the effectiveness of a treatment by assessing the proportion of patients who achieve either a partial or complete objective response to the treatment.
  measure: Overall survival
  time frame: The time from randomization to death from any cause, whichever came first, assessed up to 36 months
  description: The time from randomization to death from any cause
  measure: Adverse Events
  time frame: Primary Outcome Measure: 1.Progression-Free Survival The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months [Time Frame: From date of randomizatio
  description: All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
  arm group label: CDK4/6 inhibitors treatment
  description: All HR+/HER2- metastatic breast cancer patients using CDK4/6 inhibitors
  intervention type: Drug
  intervention name: Different treatment regimens following progression on CDK4/6 inhibitors.
  description: This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4/6 inhibitors combined with endocrine therapy. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4/6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be evaluated.
  arm group label: CDK4/6 inhibitors treatment
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ning Xie, Dr.
  phone: +860731-89762161
  email: xiening@hnca.org.cn
  last name: Ting Liu, Ms.
  phone: +860731-89762815
  email: liuting@hnca.org.cn
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No