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/NCT06027541</url>
    </required_header>
    <id_info>
      <org_study_id>YEBC</org_study_id>
      <nct_id>NCT06027541</nct_id>
    </id_info>
    <brief_title>Young Patients With Early Breast Cancer</brief_title>
    <official_title>Prospective Research of Young Patients With Early Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College 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>
        The prognosis of young patients with breast cancer is relatively poor. Chemotherapy damages&#xD;
        ovarian function. Endocrine treatment for up to 10 years delays the childbearing time of&#xD;
        patients. Treatment regimens in young breast cancer patients are still controversial in the&#xD;
        following: 1. Exemption from chemotherapy based on gene prediction results; 2. Removing drugs&#xD;
        that damage ovarian function from chemotherapy regimens; 3. Giving ovarian protection drugs&#xD;
        during chemotherapy for patients with hormone receptor (HR)+; 4. The right time to get&#xD;
        pregnant. In view of the above problems, the treatment scheme recommended in the guidelines&#xD;
        cannot meet the personalized needs of young breast cancer patients. The project plans to&#xD;
        establish a prognosis model for young patients with breast cancer, and provide the patients&#xD;
        hierarchical and refined management, which is significant for prolonging survival time,&#xD;
        improving quality of life, and protecting fertility. This project plans to observe the&#xD;
        relationship between the characteristics of immune genes, pathological staging, molecular&#xD;
        typing, treatment plans and prognosis in the cohort of young breast cancer patients, and&#xD;
        establish a young breast cancer prognosis model and verify it. The project is expected to&#xD;
        establish a prognosis model and provide a hierarchical and personalized precision treatment&#xD;
        plan for young breast cancer patients, so as to prolong the survival time, improve the&#xD;
        fertility rate, and improve the quality of life.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>5-year disease free survival (DFS)</measure>
      <time_frame>5 year</time_frame>
      <description>DFS: From the time of surgery to the time of recurrence or metastasis, calculated on a monthly basis, until the most recent discovery of recurrence or metastasis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>5-year overall survival (OS)</measure>
      <time_frame>5-year</time_frame>
      <description>OS: From the time of surgery to death from any cause, calculated on a monthly basis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-year recurrence</measure>
      <time_frame>5-year</time_frame>
      <description>Recurrence: Recurrence in the ipsilateral breast, axillary, or supraclavicular lymph nodes comfired by pathological biopsy confirmation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-year metastasis</measure>
      <time_frame>5-year</time_frame>
      <description>Metastasis: metastasis was detected by CT, MRI, nuclide scanning or ultrasound in liver, lung, bone, brain, and other areas, without being confirmed by pathology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the correlation between poor characteristics and survival</measure>
      <time_frame>5-year</time_frame>
      <description>clinical characteristics': T stage, N stage, tumor grade, age group, with or without ovaian protection, with or without chemotherapy/radiotherapy, operation method.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Breast Cancer Female</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>operation</intervention_name>
      <description>operation methods: breast-conserving surgery, mastectomy, axillary lymph node dissection, sentinal lymphnodes biopsy; chemotherapy regimens: AC, TC, AC-T/P, TCrb, TAC, capecitabine; ovarian protection:GnRHa; endocrine therapy: Aromatase inhibitor, GnRHa, TAM, Fulvestrant, CDK4/6 inhibitors; target therapy: trastuzumab，patuzumab, Pyrotinib.</description>
      <other_name>chemotherapy</other_name>
      <other_name>radiotherapy</other_name>
      <other_name>endocrine therapy</other_name>
      <other_name>targeted therapy</other_name>
      <other_name>ovarian protection</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        breast cancer tissue&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          patients with breast cancer receiving operation in Peking Union Medical College Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with breast cancer received operation in Peking Union Medical College&#xD;
               Hospital&#xD;
  &#xD;
            -  age ≤40 year old and ≥20 years old&#xD;
  &#xD;
            -  treatment regimen was made in Peking Union Medical College Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients without pathological information&#xD;
  &#xD;
            -  patients with metastasis&#xD;
  &#xD;
            -  patients with history of other malignant tumor (except for completely cured cervical&#xD;
               carcinoma in situ or basal cell carcinoma or squamous cell skin carcinoma)&#xD;
  &#xD;
            -  patients with palliative resection of breast&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>January 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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>young patients</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_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/NCT06027541
  org study id: YEBC
  nct id: NCT06027541
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The prognosis of young patients with breast cancer is relatively poor. Chemotherapy damages
        ovarian function. Endocrine treatment for up to 10 years delays the childbearing time of
        patients. Treatment regimens in young breast cancer patients are still controversial in the
        following: 1. Exemption from chemotherapy based on gene prediction results; 2. Removing drugs
        that damage ovarian function from chemotherapy regimens; 3. Giving ovarian protection drugs
        during chemotherapy for patients with hormone receptor (HR)+; 4. The right time to get
        pregnant. In view of the above problems, the treatment scheme recommended in the guidelines
        cannot meet the personalized needs of young breast cancer patients. The project plans to
        establish a prognosis model for young patients with breast cancer, and provide the patients
        hierarchical and refined management, which is significant for prolonging survival time,
        improving quality of life, and protecting fertility. This project plans to observe the
        relationship between the characteristics of immune genes, pathological staging, molecular
        typing, treatment plans and prognosis in the cohort of young breast cancer patients, and
        establish a young breast cancer prognosis model and verify it. The project is expected to
        establish a prognosis model and provide a hierarchical and personalized precision treatment
        plan for young breast cancer patients, so as to prolong the survival time, improve the
        fertility rate, and improve the quality of life.
  observational model: Cohort
  time perspective: Prospective
  measure: 5-year disease free survival (DFS)
  time frame: 5 year
  description: DFS: From the time of surgery to the time of recurrence or metastasis, calculated on a monthly basis, until the most recent discovery of recurrence or metastasis.
  measure: 5-year overall survival (OS)
  time frame: 5-year
  description: OS: From the time of surgery to death from any cause, calculated on a monthly basis.
  measure: 5-year recurrence
  time frame: 5-year
  description: Recurrence: Recurrence in the ipsilateral breast, axillary, or supraclavicular lymph nodes comfired by pathological biopsy confirmation.
  measure: 5-year metastasis
  time frame: 5-year
  description: Metastasis: metastasis was detected by CT, MRI, nuclide scanning or ultrasound in liver, lung, bone, brain, and other areas, without being confirmed by pathology.
  measure: the correlation between poor characteristics and survival
  time frame: 5-year
  description: clinical characteristics': T stage, N stage, tumor grade, age group, with or without ovaian protection, with or without chemotherapy/radiotherapy, operation method.
  intervention type: Procedure
  intervention name: operation
  description: operation methods: breast-conserving surgery, mastectomy, axillary lymph node dissection, sentinal lymphnodes biopsy; chemotherapy regimens: AC, TC, AC-T/P, TCrb, TAC, capecitabine; ovarian protection:GnRHa; endocrine therapy: Aromatase inhibitor, GnRHa, TAM, Fulvestrant, CDK4/6 inhibitors; target therapy: trastuzumab，patuzumab, Pyrotinib.
  other name: chemotherapy
  other name: radiotherapy
  other name: endocrine therapy
  other name: targeted therapy
  other name: ovarian protection
  breast cancer tissue
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Breast Neoplasms