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/NCT05999149</url>
    </required_header>
    <id_info>
      <org_study_id>SCHBCC-N060</org_study_id>
      <nct_id>NCT05999149</nct_id>
    </id_info>
    <brief_title>A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)</brief_title>
    <official_title>A Randomized, Open Label, Multicenter Phase III Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</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>
        This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible&#xD;
        subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab&#xD;
        with or without famitinib neoadjuvant therapy. Stratification was performed at randomization&#xD;
        according to the following factors: clinical stage of the tumor (stage II; Stage III) and CD8&#xD;
        expression status (IHC ≥10%, &lt; 10%). Subjects who have completed neoadjuvant therapy and are&#xD;
        suitable for surgery are required to undergo surgery. Subjects in the experimental group will&#xD;
        continue to receive carrilizumab and famitinib until one year from the start of neoadjuvant&#xD;
        therapy, and subjects in the control group will continue to receive carrilizumab until one&#xD;
        year from the start of neoadjuvant therapy.&#xD;
  &#xD;
        Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy&#xD;
        evaluation according to RECIST1.1 before surgery; subjects suitable for surgery received&#xD;
        surgical treatment, and pathological evaluation of tumor efficacy was performed after&#xD;
        surgery.&#xD;
  &#xD;
        During the study treatment, if the subjects show disease progression, toxicity intolerance,&#xD;
        withdrawal of informed consent, or the investigator determines that medication must be&#xD;
        terminated, the study treatment will be terminated, and follow-up will continue, including&#xD;
        disease recurrence and metastasis and safety follow-up.&#xD;
  &#xD;
        Participants who complete surgical treatment will be followed for at least 2 years for&#xD;
        event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival&#xD;
        (DDFS), and safety assessment. Safety data should be collected from the signing of the&#xD;
        informed consent until 28 days after the end of the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</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>Pathological complete response (pCR) rate</measure>
      <time_frame>Up to approximately 24 weeks</time_frame>
      <description>the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Event-free Survival (EFS) as assessed by Investigator</measure>
      <time_frame>At least 2 years</time_frame>
      <description>EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free Survival (DFS) as assessed by Investigator</measure>
      <time_frame>At least 2 years</time_frame>
      <description>DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distant Disease-free Survival (DDFS) as assessed by Investigator</measure>
      <time_frame>At least 2 years</time_frame>
      <description>DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR) in accordance with RECIST v1.1</measure>
      <time_frame>Up to approximately 24 weeks</time_frame>
      <description>Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.</measure>
      <time_frame>Up to approximately 67 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">424</enrollment>
    <condition>TNBC - Triple-Negative Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Camrelizumab Plus Chemotherapy and Famitinib</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Camrelizumab Plus Chemotherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Camrelizumab Plus Chemotherapy and Famitinib</intervention_name>
      <description>camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib</description>
      <arm_group_label>Arm A</arm_group_label>
      <other_name>camrelizumab+chemotherapy+Famitinib</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Camrelizumab Plus Chemotherapy</intervention_name>
      <description>Camrelizumab Plus Chemotherapy</description>
      <arm_group_label>Arm B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion Criteria:&#xD;
  &#xD;
          ECOG Performance Status of 0-1. Early or locally advanced, histologically documented TNBC&#xD;
          (absence of HER2, ER, and PR expression).&#xD;
  &#xD;
          Tumor stage: II-III. Adequate hematologic and organ function. Must be willing to use an&#xD;
          adequate method of contraception for the course of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a history of breast cancer. Has a history of invasive malignancy ≤5 years prior to&#xD;
               signing informed consent except for adequately treated basal cell or squamous cell&#xD;
               skin cancer or in situ cervical cancer.&#xD;
  &#xD;
          Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12&#xD;
          months.&#xD;
  &#xD;
          Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1),&#xD;
          anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent&#xD;
          directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated&#xD;
          antigen-4 [CTLA-4].&#xD;
  &#xD;
          Has a diagnosis of immunodeficiency or autoimmune diseases. Has received any form of&#xD;
          immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.&#xD;
  &#xD;
          Severe pulmonary or cardiac disease. Known active hepatitis C virus, or known active&#xD;
          hepatitis B virus. History of organ or bone marrow transplantation. Pregnant or&#xD;
          breast-feeding women. Patients who have previously received VEGFR-like small molecule&#xD;
          tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.)&#xD;
          (except bevacizumab); Urine routine indicated urinary protein ≥2+ and confirmed urinary&#xD;
          protein quantity &gt; 1g at 24h;&#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_contact>
      <last_name>chen li, MD</last_name>
      <phone>+86-021-64175590</phone>
      <email>chen_li@fudan.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Zhimin Shao</investigator_full_name>
      <investigator_title>Director of General Surgery of Fudan Shanghai Cancer Center</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05999149
  org study id: SCHBCC-N060
  nct id: NCT05999149
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible
        subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab
        with or without famitinib neoadjuvant therapy. Stratification was performed at randomization
        according to the following factors: clinical stage of the tumor (stage II; Stage III) and CD8
        expression status (IHC ≥10%, < 10%). Subjects who have completed neoadjuvant therapy and are
        suitable for surgery are required to undergo surgery. Subjects in the experimental group will
        continue to receive carrilizumab and famitinib until one year from the start of neoadjuvant
        therapy, and subjects in the control group will continue to receive carrilizumab until one
        year from the start of neoadjuvant therapy.
  
        Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy
        evaluation according to RECIST1.1 before surgery; subjects suitable for surgery received
        surgical treatment, and pathological evaluation of tumor efficacy was performed after
        surgery.
  
        During the study treatment, if the subjects show disease progression, toxicity intolerance,
        withdrawal of informed consent, or the investigator determines that medication must be
        terminated, the study treatment will be terminated, and follow-up will continue, including
        disease recurrence and metastasis and safety follow-up.
  
        Participants who complete surgical treatment will be followed for at least 2 years for
        event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival
        (DDFS), and safety assessment. Safety data should be collected from the signing of the
        informed consent until 28 days after the end of the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pathological complete response (pCR) rate
  time frame: Up to approximately 24 weeks
  description: the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
  measure: Event-free Survival (EFS) as assessed by Investigator
  time frame: At least 2 years
  description: EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
  measure: Disease-free Survival (DFS) as assessed by Investigator
  time frame: At least 2 years
  description: DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.
  measure: Distant Disease-free Survival (DDFS) as assessed by Investigator
  time frame: At least 2 years
  description: DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
  measure: Objective response rate (ORR) in accordance with RECIST v1.1
  time frame: Up to approximately 24 weeks
  description: Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
  measure: Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
  time frame: Up to approximately 67 weeks
  arm group label: Arm A
  arm group type: Experimental
  description: Camrelizumab Plus Chemotherapy and Famitinib
  arm group label: Arm B
  arm group type: Active Comparator
  description: Camrelizumab Plus Chemotherapy
  intervention type: Drug
  intervention name: Camrelizumab Plus Chemotherapy and Famitinib
  description: camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib
  arm group label: Arm A
  other name: camrelizumab+chemotherapy+Famitinib
  intervention type: Drug
  intervention name: Camrelizumab Plus Chemotherapy
  description: Camrelizumab Plus Chemotherapy
  arm group label: Arm B
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: chen li, MD
  phone: +86-021-64175590
  email: chen_li@fudan.edu.cn
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Zhimin Shao
  investigator title: Director of General Surgery of Fudan Shanghai Cancer Center
  mesh term: Breast Neoplasms
  mesh term: Triple Negative Breast Neoplasms
  sharing ipd: Undecided