<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/NCT04437160</url>
  </required_header>
  <id_info>
    <org_study_id>LC2019L06</org_study_id>
    <nct_id>NCT04437160</nct_id>
  </id_info>
  <brief_title>Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy</brief_title>
  <official_title>A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy&#xD;
      compared with observation in triple negative breast cancer (TNBC) patients with residual&#xD;
      invasive disease after platinum and taxanes based neoadjuvant chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, randomized, phase II study. TNBC patients with residual&#xD;
      invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after&#xD;
      platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are&#xD;
      assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks&#xD;
      after surgery. Patients in the chemotherapy group are given anthracycline combined with&#xD;
      cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are&#xD;
      collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2026</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>RFS</measure>
    <time_frame>median 5 years</time_frame>
    <description>RFS defined as the time from randomization to the first recurrence event or death through the end of study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>median 5 years</time_frame>
    <description>OS defined as the time from randomization to all-cause death through the end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with adverse events</measure>
    <time_frame>2-3 years</time_frame>
    <description>To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patient-reported quality of life</measure>
    <time_frame>2-3 years</time_frame>
    <description>To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">286</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Adjuvant chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.&#xD;
Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epirubicin or Pirarubicin</intervention_name>
    <description>Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d*4cycls</description>
    <arm_group_label>Adjuvant chemotherapy</arm_group_label>
    <other_name>EPI or THP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide 600mg/m2 IV, q21d*4cycls</description>
    <arm_group_label>Adjuvant chemotherapy</arm_group_label>
    <other_name>CTX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed invasive adenocarcinoma of the breast.&#xD;
&#xD;
          -  Triple negative breast cancer: hormone receptor negative (ER &lt; 10% and PgR &lt; 10%) and&#xD;
             HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology&#xD;
             laboratory.&#xD;
&#xD;
          -  Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant&#xD;
             chemotherapy.&#xD;
&#xD;
          -  Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least&#xD;
             4 cycles and no tumor progression occurred.&#xD;
&#xD;
          -  Patients should have undergone adequate tumor excision in the breast and lymph nodes&#xD;
             after neoadjuvant chemotherapy.&#xD;
&#xD;
          -  Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary&#xD;
             lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.&#xD;
&#xD;
          -  ECOG Performance Status: 0-1.&#xD;
&#xD;
          -  Patients without severe heart, lung, liver and kidney disease.&#xD;
&#xD;
          -  Adequate hematologic and end-organ function.&#xD;
&#xD;
          -  No more than 6 weeks may elapse between definitive breast surgery and randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum&#xD;
             and taxanes).&#xD;
&#xD;
          -  Previous neoadjuvant chemotherapy with platinum or taxanes alone.&#xD;
&#xD;
          -  Patients have received other adjuvant therapy.&#xD;
&#xD;
          -  Comprehensive medical examinations have revealed distant metastases before&#xD;
             randomization.&#xD;
&#xD;
          -  Patients who are not suitable for anthracycline evaluated by investigators.&#xD;
&#xD;
          -  Prior history of other malignancy (except carcinoma in situ).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pin ZHANG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pin ZHANG, MD</last_name>
    <phone>008601-87788120</phone>
    <email>Zhang_pin@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital &amp; Institute Chinese Academy of Medical Sciences (CAMS)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pin ZHANG, MD</last_name>
      <phone>13701275563</phone>
      <email>Zhang_pin@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Pin Zhang</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Triple negative breast cancer</keyword>
  <keyword>Neoadjuvant chemotherapy</keyword>
  <keyword>Residual invasive breast cancer</keyword>
  <keyword>Adjuvant chemotherapy</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Epirubicin</mesh_term>
    <mesh_term>Pirarubicin</mesh_term>
  </intervention_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/NCT04437160
org study id: LC2019L06
nct id: NCT04437160
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy
      compared with observation in triple negative breast cancer (TNBC) patients with residual
      invasive disease after platinum and taxanes based neoadjuvant chemotherapy.
This study is a multi-center, randomized, phase II study. TNBC patients with residual
      invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after
      platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are
      assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks
      after surgery. Patients in the chemotherapy group are given anthracycline combined with
      cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are
      collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: RFS
time frame: median 5 years
description: RFS defined as the time from randomization to the first recurrence event or death through the end of study
measure: OS
time frame: median 5 years
description: OS defined as the time from randomization to all-cause death through the end of study
measure: Percentage of patients with adverse events
time frame: 2-3 years
description: To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0
measure: Changes in patient-reported quality of life
time frame: 2-3 years
description: To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30
arm group label: Adjuvant chemotherapy
arm group type: Experimental
description: Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.
Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles.
arm group label: Observation
arm group type: No Intervention
description: No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.
intervention type: Drug
intervention name: Epirubicin or Pirarubicin
description: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d*4cycls
arm group label: Adjuvant chemotherapy
other name: EPI or THP
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide 600mg/m2 IV, q21d*4cycls
arm group label: Adjuvant chemotherapy
other name: CTX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pin ZHANG, MD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Pin ZHANG, MD
phone: 008601-87788120
email: Zhang_pin@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Pin Zhang
investigator title: Clinical Professor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Cyclophosphamide
mesh term: Epirubicin
mesh term: Pirarubicin
sharing ipd: No