<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/NCT04481763</url>
  </required_header>
  <id_info>
    <org_study_id>JCL2020</org_study_id>
    <nct_id>NCT04481763</nct_id>
  </id_info>
  <brief_title>A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast</brief_title>
  <official_title>A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangxi Provincial Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangxi Provincial 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>
      This is a open-labeled, single-arm, Investigator-initiated clinical trial of camrelizumab (an&#xD;
      anti-PD-1 antibody) in combination with radiotherapy in patients with early triple-negative&#xD;
      breast cancer. We will enroll 60 subjects. This study aims to evaluate the efficacy and&#xD;
      safety of camrelizumab combined with radiotherapy in the treatment of early TNBC。&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, multi-center, and exploratory clinical study, taking the Cancer&#xD;
      Hospital of Jiangxi province as the lead unit, combined with breast cancer diagnosis and&#xD;
      treatment norms, multi-center collaborative research to explore the iDFS of radiotherapy&#xD;
      combined with carilizumab for triple-negative breast cancer of different subtypes and provide&#xD;
      optimal personalized treatment options.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
  <phase>Phase 1/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>Invasive disease-free survival (iDFS)</measure>
    <time_frame>3 years</time_frame>
    <description>time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Invasive disease-free survival (iDFS)</measure>
    <time_frame>5years</time_frame>
    <description>time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>5years</time_frame>
    <description>time from randomization to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease-free survival (DFS)</measure>
    <time_frame>5 years</time_frame>
    <description>The time between randomization and recurrence of disease or (for any reason) death.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Triple-Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>camrelizumab + radiotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a open-labeled, single-arm, Investigator-initiated clinical trial ,Compared with historical data</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>Camrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks)</description>
    <arm_group_label>camrelizumab + radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiotherapy</intervention_name>
    <description>radiotherapy</description>
    <arm_group_label>camrelizumab + radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. female participants aged ≥ 18 years and &lt; 75 years&#xD;
&#xD;
          2. Participants with a histological or cytological diagnosis of TNBC breast cancer ,&#xD;
             defined by ER &lt;1%, PR &lt;1% and HER2 negative on IHC and/or non-amplified by ISH by&#xD;
             local lab testing&#xD;
&#xD;
          3. Gene detection for Subtypes of TNBC、PD-L1expression and TMB expression&#xD;
&#xD;
          4. Breast-conserving therapy is planned after mastectomy 1) largest focus must measure of&#xD;
             Primary tumor ≥ 5cm，Tumor invades breast skin and chest wall 2) Axillary lymph node&#xD;
             metastasis≥4 3) 1 -3 lymph node metastases in stage T1-2 4) Simple mastectomy combined&#xD;
             with axillary lymphadenectomy in stage T1-2 (axillary lymph nodes are positive, and&#xD;
             subsequent axillary dissection is not considered)&#xD;
&#xD;
          5. Adequate Organ Function as defined in the table below:&#xD;
&#xD;
             Absolute neutrophil count (ANC) ≥ 1500/uL Platelet count ≥ 100,000/uL Hemoglobin&#xD;
             ≥5.6mmol/L（9.0g/dL) serum albumin ≥2.8g/dL Serum creatinine ≤ ≤1.5mg/d or creatinine&#xD;
             clearance ≥ 50mL/min Serum Total Bilirubin ≤ 1.5 X ULN AST&amp;ALT≤2.5ULN&#xD;
&#xD;
          6. 12 lead ECG: friderica corrected QT interval (QTCF) &lt; 470 Ms&#xD;
&#xD;
          7. Women of childbearing potential must have a negative urine or serum pregnancy test&#xD;
             within 28 day prior to registration; women/men of reproductive potential must have&#xD;
             agreed to use an effective contraceptive method for the course of the study through 90&#xD;
             days after the last dose of study medication.&#xD;
&#xD;
          8. Written informed consent obtained from subject and ability for subject to comply with&#xD;
             the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known additional malignancy that is progressing or has required active treatment .&#xD;
&#xD;
             Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of&#xD;
             the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that&#xD;
             have undergone potentially curative therapy are not excluded.&#xD;
&#xD;
          2. Patients with evident metastatic lesions at the time of diagnosis&#xD;
&#xD;
          3. Has received prior therapy with an anti-PD-1, anti-PD-L1.History of severe allergic,&#xD;
             anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies&#xD;
             or fusion proteins&#xD;
&#xD;
          4. There are any active autoimmune diseases or a medical history of autoimmune&#xD;
             (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis,&#xD;
             enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism,&#xD;
             thyroid function Decreased. Subjects with vitiligo or adults who have had childhood&#xD;
             asthma but have fully relieved without any intervention may be included. However,&#xD;
             subjects who require bronchodilators for medical intervention cannot be included.)&#xD;
&#xD;
          5. Active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
             drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment.&#xD;
&#xD;
          6. Ascites or pleural effusion with clinical symptoms, requiring therapeutic puncture or&#xD;
             drainage&#xD;
&#xD;
          7. Cardiac clinical symptoms or diseases that are not well controlled, such as: a. Heart&#xD;
             Failure NYHA &gt; Class Ⅱ, b. unstable angina, c. myocardial infarction within 1 year; d.&#xD;
             Clinically significant supraventricular or ventricular arrhythmia requiring treatment&#xD;
             or intervention.&#xD;
&#xD;
          8. Abnormal coagulation function (PT&gt;16s, APTT&gt;43s, TT&gt;21s, Fbg&lt;2g/L), with obvious&#xD;
             bleeding tendency or undergoing thrombolytic or anticoagulant treatment&#xD;
&#xD;
          9. History of clear tendency of gastrointestinal hemorrhage and active bleeding in&#xD;
             unresected tumor within 3 months prior to the start of study treatment. for example,&#xD;
             esophageal varices, gastric and duodenal active ulcer, ulcerative colitis, portal&#xD;
             hypertension ; Or other conditions that may cause gastrointestinal bleeding and&#xD;
             perforation determined by the researchers;&#xD;
&#xD;
         10. Previous or current serious bleeding (bleeding &gt; 30ml in 3 months), hemoptysis (fresh&#xD;
             blood &gt; 5ml in 4 weeks) or thromboembolism within 12 months (including stroke events&#xD;
             and / or transient ischemic attacks);&#xD;
&#xD;
         11. The patient has active infection during screening period, or unexplained fever (≥38.5&#xD;
             °C) before first administration ( According to the judgment of the researcher, the&#xD;
             fever caused by the tumor can be included in the group);&#xD;
&#xD;
         12. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 4&#xD;
             weeks prior to the start of study treatment;&#xD;
&#xD;
         13. Has a history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced&#xD;
             pneumonitis, organising pneumonia (i.e., bronchiolitis obliterans, cryptogenic&#xD;
             organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan.&#xD;
&#xD;
         14. Subjects with congenital or acquired immunodeficiency (such as HIV-infected), or&#xD;
             active hepatitis (hepatitis B reference: HBsAg-positive, HBV DNA ≥ 2000 IU/ml or copy&#xD;
             number ≥ 104/ml; hepatitis C reference: HCV antibody-positive.)&#xD;
&#xD;
         15. Patients who are participating in other clinical trials or less than 1 month from the&#xD;
             end of the previous clinical study; Patients may receive other systemic anti-tumor&#xD;
             treatment during the study period&#xD;
&#xD;
         16. Receive live vaccine within 4 weeks before or during the study period;&#xD;
&#xD;
         17. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
         18. According to the investigator's assessment, there are other factors that may lead to&#xD;
             the termination of the study, such as other serious diseases (including mental&#xD;
             illness) requiring combined treatment. Any other condition and social/psychological&#xD;
             problems, etc., the investigator judged that the patient was not suitable for&#xD;
             participation in 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>Chunling Jiang</last_name>
    <phone>+86 13764066064</phone>
    <email>jclil2002@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chunling Jiang</name>
      <address>
        <city>NanCHang</city>
        <state>Jiang XI</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chunling Jiang, doctor</last_name>
      <phone>13979109200</phone>
      <phone_ext>+086</phone_ext>
      <email>jclil2002@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</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>Triple Negative 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>


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/NCT04481763
org study id: JCL2020
nct id: NCT04481763
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a open-labeled, single-arm, Investigator-initiated clinical trial of camrelizumab (an
      anti-PD-1 antibody) in combination with radiotherapy in patients with early triple-negative
      breast cancer. We will enroll 60 subjects. This study aims to evaluate the efficacy and
      safety of camrelizumab combined with radiotherapy in the treatment of early TNBC。
This trial is a prospective, multi-center, and exploratory clinical study, taking the Cancer
      Hospital of Jiangxi province as the lead unit, combined with breast cancer diagnosis and
      treatment norms, multi-center collaborative research to explore the iDFS of radiotherapy
      combined with carilizumab for triple-negative breast cancer of different subtypes and provide
      optimal personalized treatment options.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Invasive disease-free survival (iDFS)
time frame: 3 years
description: time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause
measure: Invasive disease-free survival (iDFS)
time frame: 5years
description: time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause
measure: Overall survival (OS)
time frame: 5years
description: time from randomization to death from any cause
measure: disease-free survival (DFS)
time frame: 5 years
description: The time between randomization and recurrence of disease or (for any reason) death.
arm group label: camrelizumab + radiotherapy
arm group type: Other
description: This is a open-labeled, single-arm, Investigator-initiated clinical trial ,Compared with historical data
intervention type: Drug
intervention name: Camrelizumab
description: Camrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks)
arm group label: camrelizumab + radiotherapy
intervention type: Radiation
intervention name: radiotherapy
description: radiotherapy
arm group label: camrelizumab + radiotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chunling Jiang
phone: +86 13764066064
email: jclil2002@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Triple Negative Breast Neoplasms
sharing ipd: No