<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/NCT04502680</url>
  </required_header>
  <id_info>
    <org_study_id>EMBRAVE-001</org_study_id>
    <nct_id>NCT04502680</nct_id>
  </id_info>
  <brief_title>Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer Patients</brief_title>
  <acronym>EMBRAVE-001</acronym>
  <official_title>A Multicenter, Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Maintenance Treatment With Eribulin Mesylate Following Standard Adjuvant Chemotherapy in Triple Negative Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is a multicenter, randomized, open-label, phase-II study to evaluate the&#xD;
      efficacy and safety of maintenance treatment with eribulin mesylate following standard&#xD;
      adjuvant chemotherapy in triple negative breast cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Triple negative breast cancer (TNBC) is an aggressive disease with high relapse rates and&#xD;
      poor overall survival. This study explores the role of maintenance treatment with eribulin&#xD;
      following standard adjuvant chemotherapy in TNBC. Patients will be randomized to receive&#xD;
      eribulin mesylate maintenance treatment or observation after standard adjuvant chemotherapy.&#xD;
&#xD;
      The primary objective is to evaluate the disease free survival (DFS). The secondary objective&#xD;
      is to evaluate the overall survival (OS), objective response rate (ORR) and the safety of&#xD;
      eribulin mesylate maintenance treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Disease Free Survival (DFS)</measure>
    <time_frame>3 years</time_frame>
    <description>DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
    <description>OS is defined as time to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>3 years</time_frame>
    <description>The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Who Experienced Adverse Events (AE)</measure>
    <time_frame>3 years</time_frame>
    <description>Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Eribulin Mesylate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive eribulin mesylate following standard adjuvant chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Observation. No intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin Mesylate</intervention_name>
    <description>Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.</description>
    <arm_group_label>Eribulin Mesylate</arm_group_label>
    <other_name>Halaven</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient volunteers and signs an informed consent form;&#xD;
&#xD;
          -  Age ≥18 years old, female;&#xD;
&#xD;
          -  The patient was diagnosed as triple-negative breast cancer by histopathology (ER&#xD;
             negative (IHC ER positive percentage &lt;1%), PR negative (IHC PR positive percentage&#xD;
             &lt;1%), HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is no evidence of&#xD;
             metastasis;&#xD;
&#xD;
          -  Patients underwent radical or breast conserving surgery combined with sentinel lymph&#xD;
             node biopsy for primary breast cancer. Margins free of disease and ductal carcinoma&#xD;
             in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.&#xD;
&#xD;
          -  For patients who have previously received neoadjuvant therapy for triple-negative&#xD;
             breast cancer containing anthracyclines and taxanes, the postoperative efficacy&#xD;
             evaluation did not reach pathological complete remission (non-PCR), that is, the&#xD;
             primary breast and/or metastatic regional lymph nodes still have histological evidence&#xD;
             of malignant tumors other than carcinoma in situ;&#xD;
&#xD;
          -  For patients who have not received neoadjuvant therapy for triple-negative breast&#xD;
             cancer, ≥1 ipsilateral axillary lymph nodes have pathological tumor involvement after&#xD;
             surgery. Or the patient's postoperative lymph nodes are negative, but at least meet&#xD;
             one of the following conditions:&#xD;
&#xD;
               1. Primary invasive tumor size&gt; 2cm in pathology;&#xD;
&#xD;
               2. Ki-67 index of untreated breast tissue&gt;30%;&#xD;
&#xD;
               3. The comprehensive score is at least 8 points (Elston and Ellis 1991) according to&#xD;
                  the improved Bloom-Richardson grading system (also known as the Nottingham&#xD;
                  scale), which belongs to the 3rd level;&#xD;
&#xD;
          -  Physical condition ECOG PS: 0-1;&#xD;
&#xD;
          -  Previously received adjuvant chemotherapy consisting of a minimum of 6 courses with&#xD;
             anthracyclines combined taxanes;&#xD;
&#xD;
          -  Time window between end of adjuvant chemotherapy and study randomization must be less&#xD;
             than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between&#xD;
             last session and randomisation is 4 weeks;&#xD;
&#xD;
          -  Laboratory tests meet the following criteria:&#xD;
&#xD;
               1. Bone marrow function: absolute count of blood neutrophils (ANC) ≥1.5×109/L;&#xD;
                  platelet (PLT)≥100×109/L; hemoglobin (HB)≥90g/L;&#xD;
&#xD;
               2. Liver function: serum total bilirubin (STB), combined bilirubin (CB) ≤ upper&#xD;
                  limit of normal (ULN) *1.5; alanine aminotransferase (ALT), aspartate&#xD;
                  aminotransferase (AST) ≤ULN*2.5;&#xD;
&#xD;
               3. Renal function: serum creatinine (Cr) ≤ ULN; endogenous creatinine clearance&#xD;
                  (Ccr) ≥ 60 ml / min (calculated using the Cockcroft-Gault formula).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic breast cancer (including contralateral axillary lymph nodes),&#xD;
             inflammatory carcinomas;&#xD;
&#xD;
          -  Previous breast cancer history (except for ipsilateral DCIS that only received local&#xD;
             treatment ≥5 years ago), malignant tumors of other histological origins (except for&#xD;
             non-melanoma skin cancer or cervical carcinoma in situ) unless the patient's tumor had&#xD;
             been completely alleviated and had not received treatment for at least 5 years before&#xD;
             the enrollment date;&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to enrollment, or surgical wounds have not healed;&#xD;
&#xD;
          -  Embolization and bleeding occurred within 4 weeks before enrollment;&#xD;
&#xD;
          -  Severe cardiovascular disease, including hypertension (BP≥160/95mmHg) uncontrolled by&#xD;
             medical treatment, unstable angina, history of myocardial infarction in the past 6&#xD;
             months, congestive heart failure&gt;NYHA II, severe heart rhythm Abnormalities and&#xD;
             pericardial effusions;&#xD;
&#xD;
          -  Severe infection requires intravenous antibiotic, antifungal or antiviral treatment;&#xD;
&#xD;
          -  Suffering from mental illness, poor compliance;&#xD;
&#xD;
          -  Researchers believe that it is not suitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wei Li</last_name>
    <phone>13851603656</phone>
    <email>real.lw@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yongmei Yin</last_name>
    <phone>13951842727</phone>
    <email>ymyin@njmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jiangsu Provincial Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 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>Breast Neoplasms</mesh_term>
    <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/NCT04502680
org study id: EMBRAVE-001
nct id: NCT04502680
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This clinical trial is a multicenter, randomized, open-label, phase-II study to evaluate the
      efficacy and safety of maintenance treatment with eribulin mesylate following standard
      adjuvant chemotherapy in triple negative breast cancer patients.
Triple negative breast cancer (TNBC) is an aggressive disease with high relapse rates and
      poor overall survival. This study explores the role of maintenance treatment with eribulin
      following standard adjuvant chemotherapy in TNBC. Patients will be randomized to receive
      eribulin mesylate maintenance treatment or observation after standard adjuvant chemotherapy.

      The primary objective is to evaluate the disease free survival (DFS). The secondary objective
      is to evaluate the overall survival (OS), objective response rate (ORR) and the safety of
      eribulin mesylate maintenance treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease Free Survival (DFS)
time frame: 3 years
description: DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
measure: Overall Survival
time frame: 3 years
description: OS is defined as time to death from any cause.
measure: Objective Response Rate (ORR)
time frame: 3 years
description: The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
measure: The Number of Participants Who Experienced Adverse Events (AE)
time frame: 3 years
description: Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
arm group label: Eribulin Mesylate
arm group type: Experimental
description: Patients receive eribulin mesylate following standard adjuvant chemotherapy.
arm group label: Observation
arm group type: No Intervention
description: Observation. No intervention.
intervention type: Drug
intervention name: Eribulin Mesylate
description: Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.
arm group label: Eribulin Mesylate
other name: Halaven
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wei Li
phone: 13851603656
email: real.lw@163.com
last name: Yongmei Yin
phone: 13951842727
email: ymyin@njmu.edu.cn
facility: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
sharing ipd: No