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/NCT05963984</url>
    </required_header>
    <id_info>
      <org_study_id>CT7001_002</org_study_id>
      <secondary_id>2023-503903-27-00</secondary_id>
      <secondary_id>Z0041001</secondary_id>
      <nct_id>NCT05963984</nct_id>
    </id_info>
    <brief_title>A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants</brief_title>
    <acronym>SUMIT-BC</acronym>
    <official_title>An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Carrick Therapeutics Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Carrick Therapeutics Limited</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</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 evaluate the safety and efficacy of samuraciclib in&#xD;
        combination with fulvestrant versus fulvestrant alone in adult participants with metastatic&#xD;
        or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor&#xD;
        (HER)2-negative breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">June 16, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical Benefit Response (CBR)</measure>
      <time_frame>From randomization until Week 24</time_frame>
      <description>CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from randomization until disease progression, or death due to any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR)</measure>
      <time_frame>Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)</time_frame>
      <description>ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)</time_frame>
      <description>DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)</time_frame>
      <description>PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0</measure>
      <time_frame>From first dose of any study intervention through 28 days after the last dose of any study intervention</time_frame>
      <description>Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Samuraciclib plasma exposure: Cmax</measure>
      <time_frame>Day 1 of Cycles 2 and 3 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Samuraciclib plasma exposure: Ctrough</measure>
      <time_frame>Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5, and 6; and within 28 days of last dose (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fulvestrant plasma exposure: Ctrough</measure>
      <time_frame>Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5 and 6; and within 28 days of last dose (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Metastatic Breast Cancer</condition>
    <condition>Locally Advanced Breast Cancer</condition>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Samuraciclib</intervention_name>
      <description>Samuraciclib tablet by mouth once a day</description>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_label>Arm B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fulvestrant</intervention_name>
      <description>Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15</description>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_label>Arm B</arm_group_label>
      <arm_group_label>Arm C</arm_group_label>
      <other_name>Faslodex</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or&#xD;
               metastatic breast cancer.&#xD;
  &#xD;
            -  Documented objective disease progression while on or within 6 months after the end of&#xD;
               the most recent therapy.&#xD;
  &#xD;
            -  Received prior AI in combination with a CDK4/6i as the last therapy&#xD;
  &#xD;
            -  Known TP53 mutation status.&#xD;
  &#xD;
            -  Participants must have measurable disease or bone only disease as defined by Response&#xD;
               Evaluation Criteria in Solid Tumors (RECIST) version 1.1.&#xD;
  &#xD;
            -  Pre/peri-menopausal participants must have commenced treatment with a luteinizing&#xD;
               hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study&#xD;
               intervention.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration&#xD;
               over the past 2 weeks.&#xD;
  &#xD;
            -  Expected life expectancy of &gt;12 weeks in the judgement of the treating investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inflammatory breast cancer.&#xD;
  &#xD;
            -  Participants with any other active malignancy within 3 years prior to enrollment,&#xD;
               except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in&#xD;
               situ of the cervix.&#xD;
  &#xD;
            -  More than 1 line of endocrine treatment for locally advanced or metastatic disease&#xD;
               treatment.&#xD;
  &#xD;
            -  Inadequate hepatic, renal, and bone marrow function.&#xD;
  &#xD;
            -  Clinically significant cardiovascular disease.&#xD;
  &#xD;
            -  Any current or prior central nervous system metastases, carcinomatous meningitis, or&#xD;
               leptomeningeal disease.&#xD;
  &#xD;
            -  Pregnant or breastfeeding women.&#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>Clinical Operations</last_name>
      <phone>+353 1 5996873</phone>
      <email>hello@carricktherapeutics.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ocala Oncology Center PL DBA Florida Cancer Affiliates</name>
        <address>
          <city>Ocala</city>
          <state>Florida</state>
          <zip>34474</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Metastatic Breast Cancer</keyword>
    <keyword>Advanced Breast Cancer</keyword>
    <keyword>Breast Cancer</keyword>
    <keyword>HR Positive</keyword>
    <keyword>HER2-Negative</keyword>
    <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>Fulvestrant</mesh_term>
    </intervention_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/NCT05963984
  org study id: CT7001_002
  secondary id: 2023-503903-27-00
  secondary id: Z0041001
  nct id: NCT05963984
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the safety and efficacy of samuraciclib in
        combination with fulvestrant versus fulvestrant alone in adult participants with metastatic
        or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor
        (HER)2-negative breast cancer.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Clinical Benefit Response (CBR)
  time frame: From randomization until Week 24
  description: CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from randomization until disease progression, or death due to any cause.
  measure: Objective Response Rate (ORR)
  time frame: Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
  description: ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause.
  measure: Duration of Response (DOR)
  time frame: Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
  description: DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
  measure: Progression Free Survival (PFS)
  time frame: Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
  description: PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
  measure: Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
  time frame: From first dose of any study intervention through 28 days after the last dose of any study intervention
  description: Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
  measure: Samuraciclib plasma exposure: Cmax
  time frame: Day 1 of Cycles 2 and 3 (each cycle is 28 days)
  measure: Samuraciclib plasma exposure: Ctrough
  time frame: Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5, and 6; and within 28 days of last dose (each cycle is 28 days)
  measure: Fulvestrant plasma exposure: Ctrough
  time frame: Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5 and 6; and within 28 days of last dose (each cycle is 28 days)
  arm group label: Arm A
  arm group type: Experimental
  description: Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
  arm group label: Arm B
  arm group type: Experimental
  description: Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
  arm group label: Arm C
  arm group type: Experimental
  description: Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.
  intervention type: Drug
  intervention name: Samuraciclib
  description: Samuraciclib tablet by mouth once a day
  arm group label: Arm A
  arm group label: Arm B
  intervention type: Drug
  intervention name: Fulvestrant
  description: Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15
  arm group label: Arm A
  arm group label: Arm B
  arm group label: Arm C
  other name: Faslodex
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Operations
  phone: +353 1 5996873
  email: hello@carricktherapeutics.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Fulvestrant
  sharing ipd: No